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510(k) K904175

RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT by Reagents Applications, Inc. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1990
Date Received
September 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
Submission Type

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  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)