PLT-4 PLATELET ANALYZER— 510(k) K853722
Substantially EquivalentTexas Intl. Laboratories, Inc.
FDA 510(k) clearance K853722 for PLT-4 PLATELET ANALYZER, Substantially Equivalent on 1986-01-17. Applicant: Texas Intl. Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Texas Intl. Laboratories, 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
- Houston, TX, US
Recent devices under product code GKL
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