510(k) K770519
- Device
- REAGENT SYSTEM 153-UV
- Applicant
- Sigma Chemical Co.
- 510(k) number
- K770519
- Product code
- JKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-06-03
- Date received
- 1977-03-18
- Regulation
- 862.1420
- Classification name
- L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
- 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
FDA Registration Numbers
- 3003741796
Source Documents
510(k) summary PDF not indicated by FDA