Home / 510(k) Clearances / K812727

510(k) K812727

GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT by Immuno Nuclear Corp. — Product Code CGC

K812727 is an FDA 510(k) premarket notification submitted by Immuno Nuclear Corp. for the device "GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 5, 1981. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. Immuno Nuclear Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1981
Date Received
September 28, 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

Other clearances by Immuno Nuclear Corp.

  • K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (December 15, 1986)
  • K863973 — ELM ALLERGEN DISC (December 1, 1986)
  • K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC (October 29, 1986)
  • K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC (October 1, 1986)
  • K863098 — MEADOW FESCUE ALLERGEN DISC (September 15, 1986)
  • K862266 — MAPLE ALLERGEN DISC (August 19, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)

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)
  • 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