510(k) K770902
- Device
- COLORIMETRIC DETERM. SOCITRATE DEHYDRO.
- Applicant
- Sigma Chemical Co.
- 510(k) number
- K770902
- Product code
- JKH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-14
- Date received
- 1977-05-16
- Regulation
- 862.1420
- Classification name
- Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2016673
Source Documents#
510(k) summary PDF not indicated by FDA