510(k) K770577
- Device
- DETER. OF PHOSPHOHEXOSE ISOMERASE
- Applicant
- Sigma Chemical Co.
- 510(k) number
- K770577
- Product code
- KLJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-17
- Date received
- 1977-03-28
- Regulation
- 862.1570
- Classification name
- Nad Reduction (U.V.), Phosphohexose Isomerase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA