ATAC 4300 HEMATOLOGY CELL COUNTER— 510(k) K863332
Substantially EquivalentTurpen Laboratory Systems, Inc.
FDA 510(k) clearance K863332 for ATAC 4300 HEMATOLOGY CELL COUNTER, Substantially Equivalent on 1986-09-29. Applicant: Turpen Laboratory Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Turpen Laboratory Systems, Inc.
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, NJ, US
Recent devices under product code GKL
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