COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA— 510(k) K874188
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K874188 for COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA, Substantially Equivalent on 1988-01-19. Applicant: Coulter Electronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code GKM
- Device class
- Class 1
- Regulation
- 21 CFR 864.6160
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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