510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965142Substantially Equivalent

Vitros Immunodiagnostics Products Free T4 Reagent Pack (Gem.1015) Free T4 Calibrators (Gem.co15)

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

K965142 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15), a class II device, cleared for Johnson & Johnson Clinical Diagnostics, Inc. on under FDA product code CEC (Radioimmunoassay, Free Thyroxine). FDA records list 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K965142.

Clearance record

Decision date
Received
(85 days to decision)
Product code
CEC Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
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 CEC

Trailing 12 months

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

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