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510(k) K802164

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. by Panmed, Inc. — Product Code CIC

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
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
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)
  • 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)
  • K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON (October 10, 1980)
  • K802160 — BUN COLOR REAGENT & BUN ACID USED (October 10, 1980)

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