HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.— 510(k) K803016
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K803016 for HELENA HEMESPEC II TOTAL HEMOGLOBIN MET., Substantially Equivalent on 1980-12-30. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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