The following data is part of a premarket notification filed by Rapid Diagnostic Laboratories, Inc. with the FDA for Hyperformance Controls (hp-controls).
| Device ID | K871694 |
| 510k Number | K871694 |
| Device Name: | HYPERFORMANCE CONTROLS (HP-CONTROLS) |
| Classification | Drug Mixture Control Materials |
| Applicant | RAPID DIAGNOSTIC LABORATORIES, INC. C/O EASTERN LABORATORIES LTD. 95 SEAVIEW BOULEVARD Port Washington, NY 11050 |
| Contact | Dhar, Ph.d. |
| Correspondent | Dhar, Ph.d. RAPID DIAGNOSTIC LABORATORIES, INC. C/O EASTERN LABORATORIES LTD. 95 SEAVIEW BOULEVARD Port Washington, NY 11050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-28 |
| Decision Date | 1987-07-07 |