K941110 is an FDA 510(k) clearance for the PARAKIT. This device is classified as a Device, Parasite Concentration (Class I - General Controls, product code LKS).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 17, 1994, 71 days after receiving the submission on March 7, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K941110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1994 |
| Decision Date | May 17, 1994 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LKS — Device, Parasite Concentration |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |