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510(k) K802161

BIURET REAGENT & TOTAL PROTEIN BLANK SOL by Panmed, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 8, 1980
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

Other clearances by Panmed, Inc.

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  • K802164 — 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (October 10, 1980)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (October 10, 1980)
  • K802159 — AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (October 10, 1980)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (October 10, 1980)
  • K802160 — BUN COLOR REAGENT & BUN ACID USED (October 10, 1980)

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  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)