Submission Details
| 510(k) Number | K991120 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 1999 |
| Decision Date | May 19, 1999 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VACUTAINER BRAND CTAD TUBE (MULTIPLE)
May 1999
Decision
47d
Days
Class 2
Risk
About This 510(k) Submission
K991120 is an FDA 510(k) clearance for the VACUTAINER BRAND CTAD TUBE (MULTIPLE), a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Becton Dickinson Vacutainer Systems (Franklin Lakes, US). The FDA issued a Cleared decision on May 19, 1999, 47 days after receiving the submission on April 2, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.
Device Classification
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
Manufacturer
Becton Dickinson Vacutainer Systems
Franklin Lakes, NJ · US
JAMES W HAYNES
15 submissions
14 cleared
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