Submission Details
| 510(k) Number | K991702 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 19, 1999 |
| Decision Date | July 28, 1999 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
K991702 is an FDA 510(k) clearance for the MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578, 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 July 28, 1999, 70 days after receiving the submission on May 19, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K991702 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 19, 1999 |
| Decision Date | July 28, 1999 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |