LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT— 510(k) K062808
Substantially EquivalentCatch Incorporated
FDA 510(k) clearance K062808 for LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, Substantially Equivalent on 2006-10-13. Applicant: Catch Incorporated. Device class: 2.
Clearance details
- Applicant
- Catch Incorporated
- 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
- Special
- Location
- Renton, WA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.