The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Apo-screen Test Set For Hdl-apolipoptein A-1.
| Device ID | K853048 |
| 510k Number | K853048 |
| Device Name: | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Contact | James F Mongiardo |
| Correspondent | James F Mongiardo PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-08-28 |