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510(k) K861855

HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET by Sterling Diagnostics, Inc. — Product Code JKF

K861855 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET". The FDA issued a decision of Substantially Equivalent on June 16, 1986. The device falls under product code JKF (Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge), a Class I device regulated under 21 CFR 862.1380. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1986
Date Received
May 14, 1986
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 Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914609 — TRIGLYCERIDES REAGENT SET (November 7, 1991)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861713 — SERUM POTASSIUM REAGENT SET (May 23, 1986)

Other clearances for product code JKF

  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)

FDA data resources