Electrolyte Controls (assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660
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
11 firms currently registered for this product code
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Teco Diagnostics
ANAHEIM, CA, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Chong Qing Teco Huayi Pharm. Co.
Shapingba Dist., Chongqing, CN
Quantimetrix Corp.
REDONDO BEACH, CA, US
Medica Corp.
BEDFORD, MA, US
Infitek Co., Ltd.
Shanghai, CN
Abbott Point Of Care Canada Limited
Ottawa Ontario, CA
Btnx Inc.
Pickering Ontario, CA
Opti Medical Systems Inc.
ROSWELL, GA, US
510(k) clearances
17 clearances for this product code
- Medica Corp.Apr 27, 1999
K990971 · EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
- Phoenix Diagnostics, Inc.May 13, 1996
K960592 · ELECTROLYTE STANDARDS
- Bionostics, Inc.Mar 1, 1996
K955630 · RNA MEDICAL HEMAT CONTROL
- Aalto Scientific, Ltd.May 2, 1995
K951435 · AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
- Quantimetrix Corp.Oct 4, 1994
K943925 · SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
- I-Stat Corp.Dec 9, 1993
K934641 · I-STAT CONTROL LEVELS 1,2,3
- Verichem Laboratories, Inc.Jul 19, 1991
K912513 · ELECTROLYTE CONTROL
- Phoenix Diagnostics, Inc.Jun 6, 1990
K902266 · ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)