510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962919Substantially Equivalent

Vitros Immunodiagnostic System

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

K962919 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC SYSTEM, a class I device, cleared for Johnson & Johnson Clinical Diagnostics, Inc. on under FDA product code KHO (Fluorometer, For Clinical Use). FDA records list 33 510(k) clearances for Johnson & Johnson Clinical Diagnostics, Inc., from to . As of , FDA records show 5 recalls naming K962919.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KHO Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
Device class
Class I
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 KHO

Trailing 12 months

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

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