K972756 is an FDA 510(k) clearance for the MODIFICATION OF EST CULTURE SYSTEM II - MYCO. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on August 1, 1997, 63 days after receiving the submission on May 30, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K972756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1997 |
| Decision Date | August 01, 1997 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |