HEMATOLOGY CALIBRATOR S-CAL— 510(k) K813375
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K813375 for HEMATOLOGY CALIBRATOR S-CAL, Substantially Equivalent on 1982-02-04. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code KSA
- Device class
- Class 2
- Regulation
- 21 CFR 864.8185
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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