The following data is part of a premarket notification filed by Preferred Micro-media with the FDA for Phenylethyl Alcohol Agar W/5%sheep Blood.
| Device ID | K851591 |
| 510k Number | K851591 |
| Device Name: | PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. Toledo, OH 43612 |
| Contact | Robert Scott |
| Correspondent | Robert Scott PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. Toledo, OH 43612 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-05-13 |