K873593 is an FDA 510(k) clearance for the BIOSURE SPECIMEN COLLECTION CONTAINER. This device is classified as a Container, Specimen Mailer And Storage, Sterile (Class I - General Controls, product code KDT).
Submitted by Biosure, Inc. (San Jose, US). The FDA issued a Cleared decision on November 25, 1987, 82 days after receiving the submission on September 4, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K873593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1987 |
| Decision Date | November 25, 1987 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KDT — Container, Specimen Mailer And Storage, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |