The following data is part of a premarket notification filed by Avanti Polar Lipids, Inc. with the FDA for Avanti Polar Lipids Vdrl Antigen Slide Test Kit With 10 X 0.5 Ml Ampules, Avanti Polar Lipids Bulk Bdrl Antigen, Avanti.
| Device ID | K992124 |
| 510k Number | K992124 |
| Device Name: | AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI |
| Classification | Antigens, Nontreponemal, All |
| Applicant | AVANTI POLAR LIPIDS, INC. 700 INDUSTRIAL PARK DR. Alabaster, AL 35007 -9105 |
| Contact | Rowena Shaw |
| Correspondent | Rowena Shaw AVANTI POLAR LIPIDS, INC. 700 INDUSTRIAL PARK DR. Alabaster, AL 35007 -9105 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-09-20 |
| Summary: | summary |