The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Esp Blood Culture System.
| Device ID | K921637 |
| 510k Number | K921637 |
| Device Name: | ESP BLOOD CULTURE SYSTEM |
| Classification | System, Blood Culturing |
| Applicant | DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Contact | Jerry W Smith |
| Correspondent | Jerry W Smith DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-07-14 |