VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
FDA 510(k) clearance K991088 · decided 1999-05-28
Clearance details
- K-number
- K991088
- Device name
- VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
- Applicant
- Becton Dickinson Vacutainer Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-04-01
- Decision date
- 1999-05-28
- Days to decision
- 57 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 Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Ster recall (Z-0253-2007) | Becton Dickinson & Company | 2006-12-06 |
| BD Vacutainer Luer Adapter; Catalog #367290 and #367300. recall (Z-1462-06) | Becton Dickinson & Company | 2006-09-09 |