SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS— 510(k) K050077
Substantially EquivalentArkray, Inc.
FDA 510(k) clearance K050077 for SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS, Substantially Equivalent on 2005-02-15. Applicant: Arkray, Inc.. Device class: 2.
Clearance details
- Applicant
- Arkray, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cortlandt Manor, NY, US
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More clearances from Arkray, Inc.
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