The following data is part of a premarket notification filed by Rapid Diagnostics, Inc. with the FDA for Rapid Drugs Of Abuse Single And Multiple Test Panels.
| Device ID | K003809 |
| 510k Number | K003809 |
| Device Name: | RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | RAPID DIAGNOSTICS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Contact | Charles C.f. Yu |
| Correspondent | Charles C.f. Yu RAPID DIAGNOSTICS, INC. 1429 ROLLINS RD. Burlingame, CA 94010 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-08 |
| Decision Date | 2001-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239037732 | K003809 | 000 |