Submission Details
| 510(k) Number | K971449 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 21, 1997 |
| Decision Date | June 17, 1997 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
Jun 1997
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K971449 is an FDA 510(k) clearance for the VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE), a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Becton Dickinson Vacutainer Systems (Franklin Lakes, US). The FDA issued a Cleared decision on June 17, 1997, 57 days after receiving the submission on April 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.
Device Classification
| Product Code | GIM — Tubes, Vacuum Sample, With Anticoagulant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1675 |
Manufacturer
Becton Dickinson Vacutainer Systems
Franklin Lakes, NJ · US
JOHN A SCHALAGO
15 submissions
14 cleared
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