TECO HOMOCYSTEINE ENZYMATIC ASSAY— 510(k) K063701
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K063701 for TECO HOMOCYSTEINE ENZYMATIC ASSAY, Substantially Equivalent on 2007-04-11. Applicant: Teco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code LPS
view all- K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
More clearances from Teco Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.