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510(k) K771947

INSULIN RIA MODULE by Inter Science Institute — Product Code CFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
October 17, 1977
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

Other clearances by Inter Science Institute

  • K771948 — GLUCAGON RIA MODULE (January 20, 1978)
  • K771953 — GASTRIN RIA MODULE (January 20, 1978)

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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)
  • K841573 — INSULIN RADIOIMMUNOASSAY KIT (May 16, 1984)