REP(TM) CK-2 STAT KIT, CAT. NO. 3074— 510(k) K893007
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K893007 for REP(TM) CK-2 STAT KIT, CAT. NO. 3074, Substantially Equivalent on 1989-07-20. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.