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510(k) K901675

APOLIPOPROTEIN A-I (APO A-I) by Sigma Chemical Co. — Product Code DEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1990
Date Received
April 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein X, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5590
Review Panel
IM
Submission Type

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  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
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  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code DEL

  • K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (November 15, 2001)
  • K900124 — APOLIPOPROTEIN B (APO B) (March 2, 1990)
  • K895160 — ORTHO *APO A-1 ELISA TEST SYSTEM (October 6, 1989)
  • K893885 — BACTON TM, BASIC TM, APO A-I REAGENT (June 21, 1989)