The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Revised Double Antibody Amphetamine.
| Device ID | K882228 |
| 510k Number | K882228 |
| Device Name: | REVISED DOUBLE ANTIBODY AMPHETAMINE |
| Classification | Radioimmunoassay, Amphetamine |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DJP |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-08-08 |