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510(k) K771948

GLUCAGON RIA MODULE by Inter Science Institute — Product Code JME

K771948 is an FDA 510(k) premarket notification submitted by Inter Science Institute for the device "GLUCAGON RIA MODULE". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code JME (Radioimmunoassay, Glucagon), a Class I device regulated under 21 CFR 862.1335. Inter Science Institute has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
October 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Glucagon
Device Class
Class I
Regulation Number
862.1335
Review Panel
CH
Submission Type

Other clearances by Inter Science Institute

  • K771947 — INSULIN RIA MODULE (January 20, 1978)
  • K771953 — GASTRIN RIA MODULE (January 20, 1978)

Other clearances for product code JME

  • K893975 — DOUBLE ANTIBODY GLUCAGON (October 31, 1989)
  • K782143 — RIA KIT, GLUCOSE (February 22, 1979)

FDA data resources