SIGMA PROCED. 245 ALKALINE PHOSPHATASE— 510(k) K841918
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K841918 for SIGMA PROCED. 245 ALKALINE PHOSPHATASE, Substantially Equivalent on 1984-06-14. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CJE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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