510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831670Substantially Equivalent

Ortho*pap-Ia Endogenous Enzyme Immuno

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

K831670 is the FDA 510(k) clearance record for ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO, a class II device, cleared for Ortho Diagnostic Systems, Inc. on under FDA product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited). FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K831670.

Clearance record

Decision date
Received
(93 days to decision)
Product code
JFH Acid Phosphatase (Prostatic), Tartrate Inhibited
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho Diagnostic Systems, Inc. 125 Mark Ave., Carpinteria CA
Third party review
No

Clearances, product code JFH

Trailing 12 months

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

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