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510(k) K781702

CALIBRATOR, BOVINE SERUM by Bio-Reagents & Diagnostics, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1978
Date Received
October 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Bio-Reagents & Diagnostics, Inc.

  • K771894 — LDH ISOENZYME CONTROL (December 22, 1977)
  • K770555 — CPK ISOENZYME CONTROL (June 3, 1977)
  • K760730 — ANTICONVULSANT CONTROL SERUM (October 7, 1976)

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