510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820934Substantially Equivalent

Syphilis Bio-Enzabead Kit

Biometics Laboratory Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820934 is the FDA 510(k) clearance record for SYPHILIS BIO-ENZABEAD KIT, a class II device, cleared for Biometics Laboratory Products on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list one 510(k) clearance for Biometics Laboratory Products. As of , FDA records show no recalls naming K820934.

Clearance record

Decision date
Received
(69 days to decision)
Product code
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Biometics Laboratory Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LIP

Trailing 12 months

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

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