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510(k) K822739

AHBD by Gilford Diagnostics — Product Code JMK

K822739 is an FDA 510(k) premarket notification submitted by Gilford Diagnostics for the device "AHBD". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase), a Class I device regulated under 21 CFR 862.1380. Gilford Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
September 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device Class
Class I
Regulation Number
862.1380
Review Panel
CH
Submission Type

Other clearances by Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831844 — DIRECT BILIRUBIN REAGENT (July 18, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K823709 — TRIGLYCERIDE REAGENT (UV) (January 7, 1983)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820975 — GILCHEM ACID PHOSPHATASE REAGENT (April 26, 1982)
  • K820976 — GIL CHEM MAGNESIUM REAGENT (April 26, 1982)

Other clearances for product code JMK

  • K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (December 27, 1999)
  • K981865 — MTM BIOSCANNER K TEST STRIPS (February 26, 1999)
  • K953452 — KETOREX C SANWA (May 2, 1996)
  • K941427 — SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (March 13, 1995)
  • K862319 — HBDH (OPTIMIZED) REAGENT (July 7, 1986)
  • K843774 — RAICHEM X-HBDH REAGENT (October 31, 1984)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K781720 — HBDH ENZYME KINETIC REAGENT SET (November 3, 1978)
  • K780073 — HBDH REAGENT SET (February 13, 1978)
  • K780104 — ULTRAZYME PLUS HBD (February 13, 1978)

FDA data resources