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510(k) K893975

DOUBLE ANTIBODY GLUCAGON by Diagnostic Products Corp. — Product Code JME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
June 2, 1989
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

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  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code JME

  • K782143 — RIA KIT, GLUCOSE (February 22, 1979)
  • K771948 — GLUCAGON RIA MODULE (January 20, 1978)