HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3— 510(k) K011169
Substantially EquivalentInternational Enzymes, Inc.
FDA 510(k) clearance K011169 for HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3, Substantially Equivalent on 2001-05-18. Applicant: International Enzymes, Inc.. Device class: 1.
Clearance details
- Applicant
- International Enzymes, Inc.
- 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
- Fallbrook, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.