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510(k) K950128

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 by Emd Chemicals, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
January 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

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  • K943004 — TOTAL PROTEIN QVET (December 9, 1994)