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. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CEF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1630
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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