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510(k) K812004

GASTRIN RIA DIAGNOSTIC KIT by Abbott Laboratories — Product Code CGC

K812004 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "GASTRIN RIA DIAGNOSTIC KIT". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
July 14, 1981
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

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  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

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)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K771953 — GASTRIN RIA MODULE (January 20, 1978)

FDA data resources