510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970016Substantially Equivalent

Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/free T3 Calibrators (Gem.c020)

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

K970016 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020), a class II device, cleared for Johnson & Johnson Clinical Diagnostics, Inc. on under FDA product code CDP (Radioimmunoassay, Total Triiodothyronine). FDA records list 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc., from to . As of , FDA records show one recall naming K970016.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Regulation
21 CFR 862.1710
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 CDP

Trailing 12 months

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

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