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510(k) K781023

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU by Icl Scientific — Product Code DEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K831383 — EVENT-TEST SLIDE (June 22, 1983)
  • K823199 — ENZYME-TEST DIGOXIN (November 29, 1982)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

Other clearances for product code DEX

  • K823765 — ANTI SERA TO HUMAN OROSCOMUCOID (December 30, 1982)
  • K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (September 26, 1980)
  • K791341 — HUMAN ALPHA, ACID GLYCOPROTEIN (August 16, 1979)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)