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510(k) K802157

BCG REAGENT SERUM ALBUMIN W/TECHNICON by Panmed, Inc. — Product Code CIX

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
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Panmed, Inc.

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  • K802154 — REAGENTS USED-QUAN. MEASURE OF SERUM (October 10, 1980)
  • K802156 — REAGENTS SERUM CREATINE USING TECHICON (October 10, 1980)
  • K802164 — 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (October 10, 1980)
  • K802161 — BIURET REAGENT & TOTAL PROTEIN BLANK SOL (October 10, 1980)
  • K802158 — POSTASSIUM BUFFER SOL. & WASH SOLUTION (October 10, 1980)
  • K802159 — AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (October 10, 1980)
  • K802162 — CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (October 10, 1980)

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