The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Syva Emit Ii Plus Amphetamines Assay.
| Device ID | K031004 |
| 510k Number | K031004 |
| Device Name: | SYVA EMIT II PLUS AMPHETAMINES ASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 500 GBC DR. Newark, DE 19702 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596068 | K031004 | 000 |
| 00630414568744 | K031004 | 000 |
| 00842768023361 | K031004 | 000 |
| 00842768014345 | K031004 | 000 |
| 00842768001864 | K031004 | 000 |
| 00842768001857 | K031004 | 000 |