The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Myreader 7.
| Device ID | K853284 |
| 510k Number | K853284 |
| Device Name: | MYREADER 7 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Contact | Nicolas Schmelzer |
| Correspondent | Nicolas Schmelzer SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-04 |