K813369 is an FDA 510(k) clearance for the GRAM STAIN REAGENTS AND KIT. This device is classified as a Stains, Microbiologic (Class I - General Controls, product code JTS).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1981, 22 days after receiving the submission on November 30, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K813369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1981 |
| Decision Date | December 22, 1981 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JTS — Stains, Microbiologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |