The following data is part of a premarket notification filed by Rapid Diagnostic Laboratories, Inc. with the FDA for Blind Controls For Drugs Of Abuse Testing.
| Device ID | K903909 |
| 510k Number | K903909 |
| Device Name: | BLIND CONTROLS FOR DRUGS OF ABUSE TESTING |
| 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 | 1990-08-22 |
| Decision Date | 1990-10-26 |