The following data is part of a premarket notification filed by Devices And Diagnostics Consulting Group with the FDA for Crosslaps Elisa.
| Device ID | K972788 |
| 510k Number | K972788 |
| Device Name: | CROSSLAPS ELISA |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | DEVICES AND DIAGNOSTICS CONSULTING GROUP 16809 BRIARDALE RD. Rockville, MD 20855 |
| Contact | Tom Tsakaris |
| Correspondent | Tom Tsakaris DEVICES AND DIAGNOSTICS CONSULTING GROUP 16809 BRIARDALE RD. Rockville, MD 20855 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1998-12-22 |
| Summary: | summary |