REP(TM) SPE PLUS-30 PROCEDURES— 510(k) K896572
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K896572 for REP(TM) SPE PLUS-30 PROCEDURES, Substantially Equivalent on 1990-01-11. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CFP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1405
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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