IMAGE-IGE— 510(k) K853025
Substantially EquivalentClinical Reference Laboratory, Inc.
FDA 510(k) clearance K853025 for IMAGE-IGE, Substantially Equivalent on 1985-08-22. Applicant: Clinical Reference Laboratory, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Reference Laboratory, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KA, US
Recent devices under product code DGC
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Data sourced from openFDA. This site is unofficial and independent of the FDA.