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510(k) K841573

INSULIN RADIOIMMUNOASSAY KIT by Sorin Biomedica, Fiat, USA, Inc. — Product Code CFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1984
Date Received
April 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoreactive Insulin
Device Class
Class I
Regulation Number
862.1405
Review Panel
CH
Submission Type

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  • K896572 — REP(TM) SPE PLUS-30 PROCEDURES (January 11, 1990)
  • K890837 — RIA-GNOST INSULIN (April 26, 1989)
  • K851071 — PHARMACIA INSULIN RIA (April 12, 1985)
  • K823939 — WAKO INSULIN TEST (January 28, 1983)