The following data is part of a premarket notification filed by Regional Media Laboratories with the FDA for Haemophilus Test Medium (broth).
| Device ID | K894848 |
| 510k Number | K894848 |
| Device Name: | HAEMOPHILUS TEST MEDIUM (BROTH) |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | REGIONAL MEDIA LABORATORIES 12076 SANTA FE DR. P.O. BOX 14428 Lenexa, KS 66215 |
| Contact | Brenda Teply |
| Correspondent | Brenda Teply REGIONAL MEDIA LABORATORIES 12076 SANTA FE DR. P.O. BOX 14428 Lenexa, KS 66215 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-31 |
| Decision Date | 1989-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838011542 | K894848 | 000 |