K853715 is an FDA 510(k) clearance for the PARA CON TM. This device is classified as a Device, Parasite Concentration (Class I - General Controls, product code LKS).
Submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on October 2, 1985, 28 days after receiving the submission on September 4, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K853715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1985 |
| Decision Date | October 02, 1985 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LKS — Device, Parasite Concentration |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |