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510(k) K963018

BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS by Bio-Rad — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1997
Date Received
August 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

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  • K930317 — REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (August 3, 1993)
  • K922053 — REP SPE PLUS (PONCEAU S) SYSTEM (August 18, 1992)
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