510(k) K823237
- Device
- BARBITURATE TEST SET #0550-050
- Applicant
- STANBIO LABORATORY
- 510(k) number
- K823237
- Product code
- DJN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-29
- Date received
- 1982-11-01
- Regulation
- 862.3150
- Classification name
- Mercury Dithiazone, Colorimetry, Barbiturate
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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