K871640 is an FDA 510(k) clearance for the ALKALINE PEPTONE WATER. This device is classified as a Culture Media, Selective Broth (Class I - General Controls, product code JSD).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 13, 1987, 16 days after receiving the submission on April 27, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K871640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1987 |
| Decision Date | May 13, 1987 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSD — Culture Media, Selective Broth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |