510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905486Substantially Equivalent

Immunowell Tpo (Microsome) Test

General Biometrics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905486 is the FDA 510(k) clearance record for IMMUNOWELL TPO (MICROSOME) TEST, a class II device, cleared for General Biometrics, Inc. on under FDA product code JNL (Immunochemical, Thyroglobulin Autoantibody). FDA records list 23 510(k) clearances for General Biometrics, Inc., from to . As of , FDA records show no recalls naming K905486.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JNL Immunochemical, Thyroglobulin Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
General Biometrics, Inc. 15222 Ave. Of Science, San Diego CA
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