REP(TM) LD-2 STAT KIT, CAT. NO. 3078— 510(k) K892818
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K892818 for REP(TM) LD-2 STAT KIT, CAT. NO. 3078, Substantially Equivalent on 1989-06-20. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code CFE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1445
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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