The following data is part of a premarket notification filed by Pharmarceutical Discovery Corp. with the FDA for Ai-photodiagnostic.
| Device ID | K940004 |
| 510k Number | K940004 |
| Device Name: | AI-PHOTODIAGNOSTIC |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | PHARMARCEUTICAL DISCOVERY CORP. 7 WESTCHESTER PLAZA Elmsford, NY 10523 |
| Contact | Solomon S Steiner, Ph.d |
| Correspondent | Solomon S Steiner, Ph.d PHARMARCEUTICAL DISCOVERY CORP. 7 WESTCHESTER PLAZA Elmsford, NY 10523 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1995-08-04 |