REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171— 510(k) K893211
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K893211 for REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171, Substantially Equivalent on 1989-06-19. Applicant: Helena Laboratories.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CEF
- 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.