510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970198Substantially Equivalent

Ifa Hep2 Kit for the Detection of Antinuclear Antibodies

Scimedx Corp., Denvill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970198 is the FDA 510(k) clearance record for IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES, a class II device, cleared for Scimedx Corp. on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 14 510(k) clearances for Scimedx Corp., from to . As of , FDA records show no recalls naming K970198.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Scimedx Corp. 400 Ford Rd., Denvill NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DHN

Trailing 12 months

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

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