JFOClass II

Fluorometric, Calcium

Clinical Chemistry · 21 CFR 862.1145

MDR events1All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

C8000 CALCIUMMar 27, 2007
OtherAbbott Manufacturing, Inc.2018433-2007-00005

Event type breakdown

Other1

Most-reported manufacturers

Abbott Manufacturing, Inc.1

Recalls

1 recall events for this product code

Remel, Inc
Open, ClassifiedOct 30, 2024
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Z-0266-2025 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Remel Co.Jun 19, 1992
K920974 · BACTIDROP ACRIDINE ORANGE