510(k) K843440
- Device
- MINGO LOG 7
- Applicant
- SIEMENS ELEMA AB
- 510(k) number
- K843440
- Product code
- DJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-04
- Date received
- 1984-09-04
- Regulation
- 862.3660
- Classification name
- Gas Chromatography, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH R RADZIUS
- Address
- Burditt, Bowles & Radzius 135 S. Lasalle St. Chicago IL US 60603 60603
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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