The following data is part of a premarket notification filed by Wyntek Diagnostics, Inc. with the FDA for Osom Mono Test 143.
| Device ID | K972231 |
| 510k Number | K972231 |
| Device Name: | OSOM MONO TEST 143 |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego, CA 92121 |
| Contact | Shu-ching Cheng |
| Correspondent | Shu-ching Cheng WYNTEK DIAGNOSTICS, INC. 6146 NANCY RIDGE DR., SUITE 101 San Diego, CA 92121 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-26 |
| Summary: | summary |