510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900277Substantially Equivalent

Enzymun Test(r) Tsh-S

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900277 is the FDA 510(k) clearance record for ENZYMUN TEST(R) TSH-S, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K900277.

Clearance record

Decision date
Received
(82 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code JLW

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