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510(k) K844332

CREATININE REAGENT FOR DEMAND ANALYZER by Advanced Biomedical Methods, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1985
Date Received
November 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Advanced Biomedical Methods, Inc.

  • K945353 — CLARIT(TM) (December 9, 1994)
  • K880949 — SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER (April 5, 1988)
  • K864866 — RESUBMISSION OF THE KLEERZIT REAGENT (March 16, 1987)
  • K852784 — ALKALINE PHOSPHATASE (July 22, 1985)
  • K852783 — SGOT/ALT REAGENT (July 22, 1985)
  • K852027 — GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (May 29, 1985)
  • K850378 — LDH REAGENT FOR DEMAND ANALYZER (March 1, 1985)
  • K850381 — MAGNESIUM REAGENT FOR DEMAND ANALYZER (March 1, 1985)
  • K850379 — DIRECT BILIRUBIN FOR DEMAND ANALYZER (March 1, 1985)
  • K850380 — INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER (March 1, 1985)

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