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510(k) K895160

ORTHO *APO A-1 ELISA TEST SYSTEM by Medical Marketing Consultants, Inc. — Product Code DEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 23, 1989
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 Medical Marketing Consultants, Inc.

  • K895277 — ORTHO APO B ELISA TEST SYSTEM (September 27, 1989)

Other clearances for product code DEL

  • K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (November 15, 2001)
  • K901675 — APOLIPOPROTEIN A-I (APO A-I) (April 26, 1990)
  • K900124 — APOLIPOPROTEIN B (APO B) (March 2, 1990)
  • K893885 — BACTON TM, BASIC TM, APO A-I REAGENT (June 21, 1989)