ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770— 510(k) K020914
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K020914 for ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770, Substantially Equivalent on 2002-05-23. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JBP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7140
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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