510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941192Substantially Equivalent

Ortho Alt Microwell Test System

Ortho Diagnostic Systems, Inc., Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941192 is the FDA 510(k) clearance record for ORTHO ALT MICROWELL TEST SYSTEM, a class I device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code CKD (Hydrazone Colorimetry, Alt/Sgpt). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K941192.

Clearance record

Decision date
Received
(428 days to decision)
Product code
CKD Hydrazone Colorimetry, Alt/Sgpt
Regulation
21 CFR 862.1030
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
510(k) summary
Summary
Third party review
No

Clearances, product code CKD

Trailing 12 months

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

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