QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2— 510(k) K993631
Substantially EquivalentSeracare Technology
FDA 510(k) clearance K993631 for QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2, Substantially Equivalent on 1999-12-09. Applicant: Seracare Technology. Device class: 1.
Clearance details
- Applicant
- Seracare Technology
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
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More clearances from Seracare Technology
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