510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941361Substantially Equivalent

Microsomal Eia Test Kit

Immunoprobe, Inc., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941361 is the FDA 510(k) clearance record for MICROSOMAL EIA TEST KIT, a class II device, cleared for Immunoprobe, Inc. on under FDA product code JNL (Immunochemical, Thyroglobulin Autoantibody). FDA records list 14 510(k) clearances for Immunoprobe, Inc., from to . As of , FDA records show no recalls naming K941361.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JNL Immunochemical, Thyroglobulin Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Immunoprobe, Inc. Columbia Sq., Washington, D.C. DC
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 October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JNL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260