ULTRACLONE ECL-01-800 CELL LINE— 510(k) K851545
Substantially EquivalentEarl-Clay Laboratories, Inc.
FDA 510(k) clearance K851545 for ULTRACLONE ECL-01-800 CELL LINE, Substantially Equivalent on 1985-05-10. Applicant: Earl-Clay Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Earl-Clay Laboratories, 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
- Novato, CA, US
Recent devices under product code KIR
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