ATS TB RAPID STAIN SET PRODUCT #034-45— 510(k) K890148
Substantially EquivalentAlpha-Tec Systems, Inc.
FDA 510(k) clearance K890148 for ATS TB RAPID STAIN SET PRODUCT #034-45, Substantially Equivalent on 1989-01-24. Applicant: Alpha-Tec Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Alpha-Tec Systems, Inc.
- Product code
- Code ICL
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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