K834579 is an FDA 510(k) clearance for the BIOSPAL 2400S. This device is classified as a Container, Specimen Mailer And Storage, Sterile (Class I - General Controls, product code KDT).
Submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 37 days after receiving the submission on December 29, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K834579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 37 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 |