510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964721Substantially Equivalent

Vitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators (Gem.c005)

Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964721 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005), a class II device, cleared for Johnson & Johnson Clinical Diagnostics, Inc. on under FDA product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine). FDA records list 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K964721.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Johnson & Johnson Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Statement
Third party review
No

Clearances, product code KLI

Trailing 12 months

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

FDA records show no clearances under product code KLI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLI, 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