HELENA ULTRA SENSITIVE CPK REAGENT/DILUE— 510(k) K801318
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K801318 for HELENA ULTRA SENSITIVE CPK REAGENT/DILUE, Substantially Equivalent on 1980-07-14. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JHX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.