ULTRACLONE ECL-01-1400 CELL LINE— 510(k) K843864
Substantially EquivalentEarl-Clay Laboratories, Inc.
FDA 510(k) clearance K843864 for ULTRACLONE ECL-01-1400 CELL LINE, Substantially Equivalent on 1984-10-17. Applicant: Earl-Clay Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Earl-Clay Laboratories, Inc.
- Product code
- Code KIT
- Device class
- Class 1
- Regulation
- 21 CFR 864.2220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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