K884720 is an FDA 510(k) clearance for the GERM TUBE SOLUTION. This device is classified as a Kit, Screening, Yeast (Class I - General Controls, product code JXC).
Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1989, 204 days after receiving the submission on November 10, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K884720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1988 |
| Decision Date | June 02, 1989 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JXC — Kit, Screening, Yeast |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |