The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc with the FDA for Enzyme Ii Calibrator.
| Device ID | K103836 |
| 510k Number | K103836 |
| Device Name: | ENZYME II CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna Marie Kath Ennis |
| Correspondent | Anna Marie Kath Ennis SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768034329 | K103836 | 000 |