510(k) K760348
- Device
- Reagent System, Sigma Procedure No. 270
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K760348
- Product code
- CCZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-27
- Date received
- 1976-08-02
- Regulation
- 862.1385
- Classification name
- Zimmerman/Norymberski, 17-Ketogenic Steroids
- 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