510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843613Substantially Equivalent

Fluorescent Treponemel Antibody-Absorb

Immuno-Products Industries, So. Bound Brook NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843613 is the FDA 510(k) clearance record for FLUORESCENT TREPONEMEL ANTIBODY-ABSORB, a class II device, cleared for Immuno-Products Industries on under FDA product code GMS (Anti-Human Globulin, Fta-Abs Test). FDA records list 12 510(k) clearances for Immuno-Products Industries, from to . As of , FDA records show no recalls naming K843613.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GMS Anti-Human Globulin, Fta-Abs Test
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Immuno-Products Industries P.O. Box 286, So. Bound Brook NJ
Third party review
No

Clearances, product code GMS

Trailing 12 months

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

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