COLORIMETRIC LDH REAGENT SET— 510(k) K820768
Substantially EquivalentBiorent Diagnostic, Inc.
FDA 510(k) clearance K820768 for COLORIMETRIC LDH REAGENT SET, Substantially Equivalent on 1982-04-14. Applicant: Biorent Diagnostic, Inc.. Device class: 2.
Clearance details
- Applicant
- Biorent Diagnostic, Inc.
- Product code
- Code CFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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