DOA - IMMUNOASSAY CUT-OFF CALIBRATOR— 510(k) K945289
Substantially EquivalentMedi-Tech, Inc.
FDA 510(k) clearance K945289 for DOA - IMMUNOASSAY CUT-OFF CALIBRATOR, Substantially Equivalent on 1994-12-13. Applicant: Medi-Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Medi-Tech, Inc.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ventura, CA, US
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