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510(k) K961276

GASTRIN EIA MODEL 06B-555017 by Biosyn , Ltd. — Product Code CGC

K961276 is an FDA 510(k) premarket notification submitted by Biosyn , Ltd. for the device "GASTRIN EIA MODEL 06B-555017". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
April 3, 1996
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 for product code CGC

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

FDA data resources