510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850386Substantially Equivalent

System 8000 Cell Counter

Baker Instructions Corp., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850386 is the FDA 510(k) clearance record for SYSTEM 8000 CELL COUNTER, a class II device, cleared for Baker Instructions Corp. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 10 510(k) clearances for Baker Instructions Corp., from to . As of , FDA records show no recalls naming K850386.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Baker Instructions Corp. 100 Cascade Dr., Allentown PA
Third party review
No

Clearances, product code GKL

Trailing 12 months

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

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