510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981312Substantially Equivalent

3Rd Generation Tsh Assay for the Bayer Immuno 1 System

Bayer Corp., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981312 is the FDA 510(k) clearance record for 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, a class II device, cleared for Bayer Corp. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 63 510(k) clearances for Bayer Corp., from to . As of , FDA records show no recalls naming K981312.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Corp. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code JLW

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