SERALYZER HEMOGLOBIN CALIBRATORS— 510(k) K822046
Substantially EquivalentMiles Laboratories, Inc.
FDA 510(k) clearance K822046 for SERALYZER HEMOGLOBIN CALIBRATORS, Substantially Equivalent on 1982-07-30. Applicant: Miles Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Miles Laboratories, Inc.
- Product code
- Code KRZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.8165
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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