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510(k) K802436

CENTRIFICHEM ALBUMIN by Union Carbide Corp. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 6, 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 Union Carbide Corp.

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  • K812536 — LINDE MARK II (September 23, 1981)
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  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K803216 — CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (January 9, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)

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