The following data is part of a premarket notification filed by Medical Marketing Consultants, Inc. with the FDA for Ortho *apo A-1 Elisa Test System.
| Device ID | K895160 |
| 510k Number | K895160 |
| Device Name: | ORTHO *APO A-1 ELISA TEST SYSTEM |
| Classification | Lipoprotein X, Antigen, Antiserum, Control |
| Applicant | MEDICAL MARKETING CONSULTANTS, INC. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Contact | Joyce Davis |
| Correspondent | Joyce Davis MEDICAL MARKETING CONSULTANTS, INC. 3 BETHESDA METRO CENTER SUITE 750 Bethesda, MD 20814 |
| Product Code | DEL |
| CFR Regulation Number | 866.5590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-23 |
| Decision Date | 1989-10-06 |