Submission Details
| 510(k) Number | K933370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
K933370 is an FDA 510(k) clearance for the STOOL TRANSPORT/PROCESSOR, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on February 17, 1994, 223 days after receiving the submission on July 9, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K933370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 09, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 223 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 |