The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Imipenem Antimicrobial Susceptibility Test Disc.
| Device ID | K964487 |
| 510k Number | K964487 |
| Device Name: | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1997-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384006731 | K964487 | 000 |