The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Dtm-dermatophyte Test Medium.
| Device ID | K832581 |
| 510k Number | K832581 |
| Device Name: | DTM-DERMATOPHYTE TEST MEDIUM |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | ACUDERM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814105021231 | K832581 | 000 |