The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Emit Ii Plus Buprenorphine Assay, Emit Ii Plus Specialty Drug Calibrator/control Level 1, Level 2 Level 3, Level 4, Emit Ii Plus Specialty Drug Control Negative, Emit Ii Plus Specialty Drug Control Positive.
| Device ID | K150606 |
| 510k Number | K150606 |
| Device Name: | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. P.O. BOX 6101, M/S 514 Newark, DE 19714 -6101 |
| Contact | Frances A. Dillon |
| Correspondent | Frances A. Dillon SIEMENS HEALTHCARE DIAGNOSTICS, INC. P.O. BOX 6101, M/S 514 Newark, DE 19714 -6101 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414601168 | K150606 | 000 |
| 00630414601151 | K150606 | 000 |
| 00630414601144 | K150606 | 000 |
| 00630414601137 | K150606 | 000 |
| 00630414601120 | K150606 | 000 |
| 00630414601113 | K150606 | 000 |
| 00630414601106 | K150606 | 000 |
| 00630414601090 | K150606 | 000 |
| 00630414601083 | K150606 | 000 |