510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983674Substantially Equivalent

Vitros Immunodiagnostic Products: Ntx Calibrators, Ntx Reagent Pack, Ntx Controls

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

K983674 is the FDA 510(k) clearance record for VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS, a class I device, cleared for Ortho-Clinical Diagnostics, Inc. on under FDA product code JMM (Column Chromatography & Color Development, Hydroxyproline). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc., from to . As of , FDA records show no recalls naming K983674.

Clearance record

Decision date
Received
(101 days to decision)
Product code
JMM Column Chromatography & Color Development, Hydroxyproline
Regulation
21 CFR 862.1400
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code JMM

Trailing 12 months

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

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