HELENA FETAL-TEK 200 MARKER— 510(k) K811695
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K811695 for HELENA FETAL-TEK 200 MARKER, Substantially Equivalent on 1981-07-01. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JJY
- 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.