MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
FDA 510(k) clearance K991702 · decided 1999-07-28
Clearance details
- K-number
- K991702
- Device name
- MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
- Applicant
- Becton Dickinson Vacutainer Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-05-19
- Decision date
- 1999-07-28
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Microtainer Serum tubes (with or without gel). recall (Z-1603-05) | Becton Dickinson & Company | 2004-10-28 |