510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965131Substantially Equivalent

Borrelia Burgdorferi Igg/igm Elisa Test System

Wampole Laboratories, Cranbury NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965131 is the FDA 510(k) clearance record for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, a class II device, cleared for Wampole Laboratories on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list 12 510(k) clearances for Wampole Laboratories, from to . As of , FDA records show no recalls naming K965131.

Clearance record

Decision date
Received
(93 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Wampole Laboratories Div. Of Carter-Wallace, Inc., Cranbury NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LSR

Trailing 12 months
2 clearances under product code LSR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260