510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821553Substantially Equivalent

Zetaphase T3 Uptake Diagnostic Kit

Amf Biological and Diagnostics Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821553 is the FDA 510(k) clearance record for ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT, a class II device, cleared for Amf Biological and Diagnostics Co. on under FDA product code KHQ (Radioassay, Triiodothyronine Uptake). FDA records list 5 510(k) clearances for Amf Biological and Diagnostics Co., from to . As of , FDA records show no recalls naming K821553.

Clearance record

Decision date
Received
(31 days to decision)
Product code
KHQ Radioassay, Triiodothyronine Uptake
Regulation
21 CFR 862.1715
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Amf Biological and Diagnostics Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KHQ

Trailing 12 months

FDA records hold no clearances under product code KHQ in the trailing twelve months.

FDA records show no clearances under product code KHQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260