The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Emit Ii Plus6-acetylmorphine Assay; Emit Ii Plus 6-am/ Ecstasy Calibrator/ Control Level 1; Emit Ii Plus 6-am / Ectasy C.
| Device ID | K102779 |
| 510k Number | K102779 |
| Device Name: | EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Siemens Healthcare Diagnostics Inc. P.O. BOX 6101 MAILBOX 514 Newark, DE 19714 |
| Contact | Janet M Fose |
| Correspondent | Janet M Fose Siemens Healthcare Diagnostics Inc. P.O. BOX 6101 MAILBOX 514 Newark, DE 19714 |
| Product Code | DJG |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768034169 | K102779 | 000 |
| 00842768034152 | K102779 | 000 |
| 00842768034145 | K102779 | 000 |
| 00842768034138 | K102779 | 000 |
| 00842768034121 | K102779 | 000 |
| 00842768034114 | K102779 | 000 |
| 00630414229591 | K102779 | 000 |