510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850302Substantially Equivalent

Suplex & Suplex Diluent

Pro-Lab, Inc., Ontario Canada M5m 1c9, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850302 is the FDA 510(k) clearance record for SUPLEX & SUPLEX DILUENT, a class I device, cleared for Pro-Lab, Inc. on under FDA product code JSK (Supplement, Culture Media). FDA records list 27 510(k) clearances for Pro-Lab, Inc., from to . As of , FDA records show no recalls naming K850302.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JSK Supplement, Culture Media
Regulation
21 CFR 866.2450
Device class
Class I
Review panel
Microbiology
Applicant
Pro-Lab, Inc. 76 Glengarry Ave., Ontario Canada M5m 1c9, CA
Third party review
No

Clearances, product code JSK

Trailing 12 months

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

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