REP(TM) LD-2 STAT KIT, CAT. NO. 3078— 510(k) K892818
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K892818 for REP(TM) LD-2 STAT KIT, CAT. NO. 3078, Substantially Equivalent on 1989-06-20. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CFE
- 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.