The following data is part of a premarket notification filed by Rapid Diagnostic Laboratories, Inc. with the FDA for New Low Level Drug Mixture Control.
| Device ID | K890030 |
| 510k Number | K890030 |
| Device Name: | NEW LOW LEVEL DRUG MIXTURE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | RAPID DIAGNOSTIC LABORATORIES, INC. C/O EASTERN LABORATORIES LTD. 95 SEAVIEW BOULEVARD Port Washington, NY 11050 |
| Contact | Dhar |
| Correspondent | Dhar 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 | 1989-01-04 |
| Decision Date | 1989-01-23 |