The following data is part of a premarket notification filed by Diasorin/american Standard Companies with the FDA for Lipoprotein (a) Spq Iii Antibody Reagent Set.
| Device ID | K994110 |
| 510k Number | K994110 |
| Device Name: | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | DIASORIN/AMERICAN STANDARD COMPANIES 9175 GUILFORD RD., SUITE 100 QUARRY PARK PLACE Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN/AMERICAN STANDARD COMPANIES 9175 GUILFORD RD., SUITE 100 QUARRY PARK PLACE Columbia, MD 21046 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 1999-12-21 |
| Summary: | summary |