K953929 is an FDA 510(k) clearance for the MID-STREAM COLLECTION SET-STERILE. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on November 16, 1995, 87 days after receiving the submission on August 21, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K953929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1995 |
| Decision Date | November 16, 1995 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LIO — Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |