SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)— 510(k) K941427

Name: FDA 510(k) clearance K941427
Creator: U.S. Food and Drug Administration
Published: 1995-03-13

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K941427 for SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH), Substantially Equivalent on 1995-03-13. Applicant: Teco Diagnostics. Device class: 1.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JMK
Device class: Class 1
Regulation: 21 CFR 862.1380
Advisory panel: Clinical Chemistry
Date received: 1994-03-24
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMK

view all

K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA6101999-12-27
K981865 — MTM BIOSCANNER K TEST STRIPS1999-02-26
K953452 — KETOREX C SANWA1996-05-02
K862319 — HBDH (OPTIMIZED) REAGENT1986-07-07
K843774 — RAICHEM X-HBDH REAGENT1984-10-31

More clearances from Teco Diagnostics

view all

K170118 — Scanostics UTI Check Application Test System2017-09-21
K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS2015-07-24
K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.