510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950979Substantially Equivalent

Hep-2000 Colorzyme Ana-Ro Test System

IMMUNO CONCEPTS, NA, Ltd., Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950979 is the FDA 510(k) clearance record for HEP-2000 COLORZYME ANA-RO TEST SYSTEM, a class II device, cleared for Immuno Concepts, Inc. on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 40 510(k) clearances for IMMUNO CONCEPTS, NA, Ltd., from to . As of , FDA records show no recalls naming K950979.

Clearance record

Decision date
Received
(90 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
Immuno Concepts, Inc. 8712 Royal Ln., Irving TX
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