MICROHEMATOCRIT CENTRIFUGE— 510(k) K864039
Substantially EquivalentPlaza Medical, Inc.
FDA 510(k) clearance K864039 for MICROHEMATOCRIT CENTRIFUGE, Substantially Equivalent on 1986-10-29. Applicant: Plaza Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Plaza Medical, Inc.
- Product code
- Code GKF
- Device class
- Class 2
- Regulation
- 21 CFR 864.5600
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
Recent devices under product code GKF
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- K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
- K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
- K981427 — STAT PROFILE M ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.