The following data is part of a premarket notification filed by Microtest with the FDA for Virapure, Chlamypure And Mycopure.
| Device ID | K914894 |
| 510k Number | K914894 |
| Device Name: | VIRAPURE, CHLAMYPURE AND MYCOPURE |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | MICROTEST 1379 BRENTFORD COVE Snelleville, GA 30278 |
| Contact | James Binker |
| Correspondent | James Binker MICROTEST 1379 BRENTFORD COVE Snelleville, GA 30278 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1991-12-18 |