IMR-90-DIPLOID-HUMAN FETAL LUNG CELL— 510(k) K841998
Substantially EquivalentBartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearance K841998 for IMR-90-DIPLOID-HUMAN FETAL LUNG CELL, Substantially Equivalent on 1984-06-27. Applicant: Bartels Immunodiagnostic Supplies, Inc.. Device class: 1.
Clearance details
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Product code
- Code KIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.2280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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