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510(k) K812727

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

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.

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  • 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)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)

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  • 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)