BAYER CLINITEK STATUS ANALYZER— 510(k) K031947
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K031947 for BAYER CLINITEK STATUS ANALYZER, Substantially Equivalent on 2003-12-19. Applicant: Bayer Healthcare, LLC. Device class: 1.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.