510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883389Substantially Equivalent

Raichem(tm) Bilirubin Conjugate Standard

Reagents Applications, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883389 is the FDA 510(k) clearance record for RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD, a class II device, cleared for Reagents Applications, Inc. on under FDA product code JIW (Calibrator, Surrogate). FDA records list 63 510(k) clearances for Reagents Applications, Inc., from to . As of , FDA records show no recalls naming K883389.

Clearance record

Decision date
Received
(126 days to decision)
Product code
JIW Calibrator, Surrogate
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Reagents Applications, Inc. 8225 Mercury Ct., San Diego CA
Third party review
No

Clearances, product code JIW

Trailing 12 months

FDA records hold no clearances under product code JIW in the trailing twelve months.

FDA records show no clearances under product code JIW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260