The following data is part of a premarket notification filed by Rapid Diagnostics, Inc. with the FDA for Rapid Opiates Test Strip Ii, Rapid Opiates Test Card Ii And Doa Multiple Drug Test Cards (up To Six Tests).
| Device ID | K020716 |
| 510k Number | K020716 |
| Device Name: | RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS) |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |