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510(k) K841963

GASTRIN RIA by Syncor Intl. Corp. — Product Code CGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
May 14, 1984
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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  • 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)