EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE— 510(k) K852391
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K852391 for EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE, Substantially Equivalent on 1985-10-01. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- 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
- Beaumont, TX, US
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