510(k) K760821
- Device
- Reagent System
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K760821
- Product code
- CJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-21
- Date received
- 1976-10-13
- Regulation
- 862.1040
- Classification name
- Hydrazone Colorimetry, Aldolase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- 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