Agent, Clearing
Pathology · 21 CFR 864.4010
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
34 firms currently registered for this product code
Helena Laboratories, Corp.
BEAUMONT, TX, US
Jellox Biotech Inc.
Hsinchu County, TW
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Phadia Us Inc.
Portage, MI, US
Agilent Technologies Inc.
Cedar Creek, TX, US
Merck Kgaa
DARMSTADT Hesse, DE
Richard-allan Scientific Llc
KALAMAZOO, MI, US
Slmp Llc D.b.a. Statlab Medical Products
McKinney, TX, US
Zhejiang Gene Science Co., Ltd
shaoxing Zhejiang, CN
Noul Co., Ltd.
Yongin Si Gyeonggi, KR
Phadia Ab
UPPSALA, SE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Phadia Ab
Uppsala, SE
Leica Biosystems Richmond, Inc.
Richmond, IL, US
Mg Developpement
mauguio Herault, FR
Mel-mont Medical Inc
Doral, FL, US
Avantor Performance Materials, Llc
Paris, KY, US
Anatech Division Of Cancer Diagnostics, Inc.
Battle Creek, MI, US
Mg Development America Inc.
Pittsburgh, PA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Creative Waste Solutions, Inc.
Tualatin, OR, US
Chaptec America
Montreal Quebec, CA
Calibrescientific Us, Inc.
VANCOUVER, WA, US
Mercedes Medical Llc
Lakewood Ranch, FL, US
510(k) clearances
15 clearances for this product code
- Anatech, Ltd.Apr 5, 1988
K881282 · XYLENE
- Chem Pharm, Inc.Dec 4, 1987
K874461 · HEMO-SOL
- Helena LaboratoriesMay 6, 1986
K861490 · PERMACLEAR SOLUTION CAT. NO. 4950
- Surgipath Medical Industries, Inc.Jan 7, 1986
K855109 · CLEARENE, CLEARING AGENT
- Lerner Laboratories, Inc.Oct 22, 1985
K853694 · XYLENE SUBSTITUTE
- Lerner Laboratories, Inc.Oct 22, 1985
K854083 · XYLENE SUBSTITUTE MONTANT
- Anatech, Ltd.Aug 21, 1984
K842861 · PRO-PAR CLEARANT
- E K Ind., Inc.Aug 3, 1984
K842721 · LIMONENE