The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Color Vue Tm- Mycoplasma Pneumoniae.
| Device ID | K910833 |
| 510k Number | K910833 |
| Device Name: | COLOR VUE TM- MYCOPLASMA PNEUMONIAE |
| Classification | Antisera, All Mycoplasma Spp. |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | Michael J Sullivan |
| Correspondent | Michael J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | GSA |
| CFR Regulation Number | 866.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-06-24 |