510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903626Substantially Equivalent

Biomek Automated Laboratory Workstation W/genelisa

Beckman Instruments, Inc., Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903626 is the FDA 510(k) clearance record for BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K903626.

Clearance record

Decision date
Received
(66 days to decision)
Product code
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Regulation
21 CFR 862.2140
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Instruments, Inc. 2500 Harbor Blvd., Fullerton CA
Third party review
No

Clearances, product code JJG

Trailing 12 months

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

FDA records show no clearances under product code JJG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJG, 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