510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K803071Substantially Equivalent

Pla-Mate

Labex, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803071 is the FDA 510(k) clearance record for PLA-MATE, a class II device, cleared for Labex, Inc. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list one 510(k) clearance for Labex, Inc. As of , FDA records show no recalls naming K803071.

Clearance record

Decision date
Received
(231 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Labex, Inc. 803 N. Front St. Suite 3, Mchenry IL
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