510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941498Substantially Equivalent

Biomek Sl with Biomek Sl Incubator

Beckman Analytical and Biotechnology Development, Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941498 is the FDA 510(k) clearance record for BIOMEK SL WITH BIOMEK SL INCUBATOR, a class I device, cleared for Beckman Analytical and Biotechnology Development on under FDA product code JQW (Station, Pipetting And Diluting, For Clinical Use). FDA records list one 510(k) clearance for Beckman Analytical and Biotechnology Development. As of , FDA records show no recalls naming K941498.

Clearance record

Decision date
Received
(108 days to decision)
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
Regulation
21 CFR 862.2750
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Beckman Analytical and Biotechnology Development 2500 Harbor Blvd., Fullerton CA
510(k) summary
Summary
Third party review
No

Clearances, product code JQW

Trailing 12 months

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

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