REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187— 510(k) K894366
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K894366 for REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187, Substantially Equivalent on 1989-08-31. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code LBT
- 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.