DS30 HCY HOMOCYSTEINE ASSAY KIT— 510(k) K982003
Substantially EquivalentDrew Scientific , Ltd.
FDA 510(k) clearance K982003 for DS30 HCY HOMOCYSTEINE ASSAY KIT, Substantially Equivalent on 1999-02-11. Applicant: Drew Scientific , Ltd.. Device class: 2.
Clearance details
- Applicant
- Drew Scientific , Ltd.
- 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
- Barrow In Furness, GB
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More clearances from Drew Scientific , Ltd.
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