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510(k) K901675

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

K901675 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "APOLIPOPROTEIN A-I (APO A-I)". The FDA issued a decision of Substantially Equivalent on April 26, 1990. The device falls under product code DEL (Lipoprotein X, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5590. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

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

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • 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)

FDA data resources