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510(k) K833119

AUTOIMMUNE TEST 1/2/3 SYSTEM by Atlantic Antibodies — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1983
Date Received
September 13, 1983
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 Atlantic Antibodies

  • K892526 — SPQ TM TEST SYSTEM II FOR CRP (May 9, 1989)
  • K891154 — SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B (March 16, 1989)
  • K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (March 3, 1989)
  • K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (February 23, 1989)
  • K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (February 22, 1989)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K890417 — SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (February 17, 1989)
  • K890415 — SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (February 17, 1989)
  • K890564 — SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (February 17, 1989)
  • K890560 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (February 15, 1989)

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  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
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