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510(k) K941427

SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) by Teco Diagnostics — Product Code JMK

K941427 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)". The FDA issued a decision of Substantially Equivalent on March 13, 1995. 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. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1995
Date Received
March 24, 1994
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 Teco Diagnostics

  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (February 4, 2011)

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)
  • K862319 — HBDH (OPTIMIZED) REAGENT (July 7, 1986)
  • K843774 — RAICHEM X-HBDH REAGENT (October 31, 1984)
  • K822739 — AHBD (October 18, 1982)
  • 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