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510(k) K972145

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM by Immuno Concepts, Inc. — Product Code DHN

K972145 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 24, 1998. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Immuno Concepts, Inc.

  • K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (November 29, 2001)
  • K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (November 14, 2001)
  • K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (November 14, 2001)
  • K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (July 23, 1999)
  • K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (December 18, 1998)
  • K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS (February 9, 1998)
  • K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM (February 9, 1998)
  • K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (September 13, 1996)
  • K955603 — RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (April 19, 1996)
  • K955604 — RELISA SM/RNP ANTIBODY TEST SYSTEM (April 19, 1996)

Other clearances for product code DHN

  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (July 28, 2016)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)

FDA data resources