Submission Details
| 510(k) Number | K872751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1987 |
| Decision Date | July 23, 1987 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K872751 is an FDA 510(k) clearance for the FLUORTRAN - C(TM), a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on July 23, 1987, 10 days after receiving the submission on July 13, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K872751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1987 |
| Decision Date | July 23, 1987 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2900 |