The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Spq Test System.
| Device ID | K982708 |
| 510k Number | K982708 |
| Device Name: | SPQ TEST SYSTEM |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN, INC. 9175 GUIFORD RD. Columbia, MD 21046 |
| Product Code | DFC |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-04 |
| Decision Date | 1999-04-02 |
| Summary: | summary |