510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921421Substantially Equivalent

Legionella Reagens for Direct Fluorescent Antibody

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

K921421 is the FDA 510(k) clearance record for LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY, a class II device, cleared for Pro-Lab, Inc. on under FDA product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent). FDA records list 27 510(k) clearances for Pro-Lab, Inc., from to . As of , FDA records show no recalls naming K921421.

Clearance record

Decision date
Received
(126 days to decision)
Product code
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Pro-Lab, Inc. 76 Glengarry Ave., Ontario Canada M5m 1c9, CA
510(k) summary
Statement
Third party review
No

Clearances, product code LHL

Trailing 12 months

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

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