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510(k) K834084

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

K834084 is an FDA 510(k) premarket notification submitted by Sterling Biochemical, Inc. for the device "HYDROXYBUTYRATE DEHYDROGENASE REAGENT". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code JKF (Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge), a Class I device regulated under 21 CFR 862.1380. Sterling Biochemical, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Sterling Biochemical, Inc.

  • K844998 — GLUCOSE(HEXOKINASE) REAGENT SET (January 18, 1985)
  • K844251 — ALT/GPT REAGENT SET (January 8, 1985)
  • 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)

FDA data resources