SGPT-UV REAGENT SET— 510(k) K821206
Substantially EquivalentOmega Medical Electronics
FDA 510(k) clearance K821206 for SGPT-UV REAGENT SET, Substantially Equivalent on 1982-07-22. Applicant: Omega Medical Electronics. Device class: 1.
Clearance details
- Applicant
- Omega Medical Electronics
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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