K871701 is an FDA 510(k) clearance for the ARYLSULFATASE BROTH. This device is classified as a Culture Media, Non-selective And Differential (Class I - General Controls, product code JSH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 20, 1987, 19 days after receiving the submission on May 1, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.
| 510(k) Number | K871701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1987 |
| Decision Date | May 20, 1987 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSH — Culture Media, Non-selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2320 |