510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964310Substantially Equivalent

Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (Gem.c010)

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

K964310 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010), 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 3 recalls naming K964310.

Clearance record

Decision date
Received
(29 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