LDH ISOENZYME REAGENT— 510(k) K781125
Substantially EquivalentElectrophoresis Corp. of America
FDA 510(k) clearance K781125 for LDH ISOENZYME REAGENT, Substantially Equivalent on 1978-08-10. Applicant: Electrophoresis Corp. of America. Device class: 2.
Clearance details
- Applicant
- Electrophoresis Corp. of America
- Product code
- Code CFE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1445
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CFE
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