CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305— 510(k) K930359
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K930359 for CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305, Substantially Equivalent on 1993-04-12. 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.