The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Mueller Hinton Agar With 2% Naci.
| Device ID | K960313 |
| 510k Number | K960313 |
| Device Name: | MUELLER HINTON AGAR WITH 2% NACI |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838002441 | K960313 | 000 |