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510(k) K771953

GASTRIN RIA MODULE by Inter Science Institute — Product Code CGC

K771953 is an FDA 510(k) premarket notification submitted by Inter Science Institute for the device "GASTRIN RIA MODULE". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. 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, Gastrin
Device Class
Class I
Regulation Number
862.1325
Review Panel
CH
Submission Type

Other clearances by Inter Science Institute

  • K771947 — INSULIN RIA MODULE (January 20, 1978)
  • K771948 — GLUCAGON RIA MODULE (January 20, 1978)

Other clearances for product code CGC

  • K961276 — GASTRIN EIA MODEL 06B-555017 (May 30, 1996)
  • K842079 — GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (June 26, 1984)
  • K841963 — GASTRIN RIA (June 25, 1984)
  • K833489 — DPC GASTRIN KIT (January 30, 1984)
  • K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU- (June 22, 1983)
  • K821175 — GASTRIN RADIOIMMUNOASSAY KIT (125-I) (May 14, 1982)
  • K812727 — GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (November 5, 1981)
  • K812004 — GASTRIN RIA DIAGNOSTIC KIT (July 28, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)

FDA data resources