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 |