The following data is part of a premarket notification filed by Apl Medical Supplies with the FDA for Apl Sabouraud Dextrose Agar.
| Device ID | K853231 |
| 510k Number | K853231 |
| Device Name: | APL SABOURAUD DEXTROSE AGAR |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | APL MEDICAL SUPPLIES 4230 S. BURNHAM AVE. #250 P.O. BOX 14280 LAS VEGAS, NV 89114 |
| Contact | JOHN WIECHEC |
| Correspondent | JOHN WIECHEC APL MEDICAL SUPPLIES 4230 S. BURNHAM AVE. #250 P.O. BOX 14280 LAS VEGAS, NV 89114 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-08-19 |