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510(k) K851842

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN by Atlantic Antibodies — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
April 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
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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  • K160712 — VITROS Chemistry Products hsCRP Reagent (July 14, 2017)
  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
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  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K121558 — DIAZYME HSCRP POC TEST KIT (September 21, 2012)