LEVEL I CONTROL SERUM— 510(k) K821557
Substantially EquivalentIrvine Scientific
FDA 510(k) clearance K821557 for LEVEL I CONTROL SERUM, Substantially Equivalent on 1982-07-08. Applicant: Irvine Scientific. Device class: 1.
Clearance details
- Applicant
- Irvine Scientific
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.