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510(k) K771947

INSULIN RIA MODULE by Inter Science Institute — Product Code CFP

K771947 is an FDA 510(k) premarket notification submitted by Inter Science Institute for the device "INSULIN RIA MODULE". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code CFP (Radioimmunoassay, Immunoreactive Insulin), a Class I device regulated under 21 CFR 862.1405. Inter Science Institute has at least 2 other 510(k) clearances on record.

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

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

Other clearances for product code CFP

  • K963911 — ALPCO/MERCODIA INSULIN ELISA (November 1, 1996)
  • K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY (September 25, 1995)
  • K920109 — IMX INSULIN (May 7, 1992)
  • K914820 — DSL INSULIN RIA (DSL 1600) (January 9, 1992)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901135 — ENZYMUN TEST(R) INSULIN (April 3, 1990)
  • 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)

FDA data resources