The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Mingo Log 7.
| Device ID | K843440 |
| 510k Number | K843440 |
| Device Name: | MINGO LOG 7 |
| Classification | Gas Chromatography, Phenobarbital |
| Applicant | SIEMENS ELEMA AB BURDITT, BOWLES & RADZIUS 135 SOUTH LASALLE STREET Chicago , IL 60603 - |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius SIEMENS ELEMA AB BURDITT, BOWLES & RADZIUS 135 SOUTH LASALLE STREET Chicago , IL 60603 - |
| Product Code | DJH |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-04 |
| Decision Date | 1984-09-04 |