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510(k) K834084

HYDROXYBUTYRATE DEHYDROGENASE REAGENT by Sterling Biochemical, Inc. — Product Code JKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
November 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge
Device Class
Class I
Regulation Number
862.1380
Review Panel
CH
Submission Type

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  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K842521 — AST/GOT REAGENT SET UV RATE (August 12, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834045 — URIC ACID REAGENT SET (January 30, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K831874 — LIPASE REAGENT SET (August 12, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

Other clearances for product code JKF

  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)