K871117 is an FDA 510(k) clearance for the TB QUICK STAIN(TM) KIT. This device is classified as a Carbol Night Blue (Class I - General Controls, product code ICJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 3, 1987, 15 days after receiving the submission on March 19, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K871117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1987 |
| Decision Date | April 03, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | ICJ — Carbol Night Blue |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |