REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083— 510(k) K896170
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K896170 for REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083, Substantially Equivalent on 1990-02-16. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JHT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.