The following data is part of a premarket notification filed by Perimmune, Inc. with the FDA for Apo-tek Lp(a).
| Device ID | K970302 |
| 510k Number | K970302 |
| Device Name: | APO-TEK LP(A) |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | PERIMMUNE, INC. 1330 PICCARD DR. Rockville, MD 20850 -4396 |
| Contact | Peter A Manilla |
| Correspondent | Peter A Manilla PERIMMUNE, INC. 1330 PICCARD DR. Rockville, MD 20850 -4396 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-27 |
| Decision Date | 1997-11-10 |
| Summary: | summary |