The following data is part of a premarket notification filed by Prepared Media Laboratory, Inc. with the FDA for Haemophilus Test Medium Agar (htm).
| Device ID | K962744 |
| 510k Number | K962744 |
| Device Name: | HAEMOPHILUS TEST MEDIUM AGAR (HTM) |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | PREPARED MEDIA LABORATORY, INC. 15845 SW 72ND AVE. BLDG. C Portland, OR 97224 |
| Contact | Gary Wicklund |
| Correspondent | Gary Wicklund PREPARED MEDIA LABORATORY, INC. 15845 SW 72ND AVE. BLDG. C Portland, OR 97224 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1996-10-15 |