The following data is part of a premarket notification filed by Accumed Intl., Inc. with the FDA for Modification Of Est Culture System Ii - Myco.
| Device ID | K972756 |
| 510k Number | K972756 |
| Device Name: | MODIFICATION OF EST CULTURE SYSTEM II - MYCO |
| Classification | System, Blood Culturing |
| Applicant | ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K Westlake, OH 44145 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-30 |
| Decision Date | 1997-08-01 |