510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K952607Substantially Equivalent

Auraflex Tpo-Ab

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952607 is the FDA 510(k) clearance record for AURAFLEX TPO-AB, a class II device, cleared for Organon Teknika Corp. on under FDA product code JNL (Immunochemical, Thyroglobulin Autoantibody). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K952607.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JNL Immunochemical, Thyroglobulin Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code JNL

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