CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE— 510(k) K902083
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K902083 for CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE, Substantially Equivalent on 1990-06-15. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code GJT
- Advisory panel
- Hematology
- 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.