The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Apo-chrome Immunoassay Test Set For Apolipoprotein.
| Device ID | K853174 |
| 510k Number | K853174 |
| Device Name: | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN |
| Classification | Apolipoproteins |
| 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 | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-08-22 |