THYRETAIN TM TSI REPORTER BIOASSAY— 510(k) K092229
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K092229 for THYRETAIN TM TSI REPORTER BIOASSAY, Substantially Equivalent on 2010-05-18. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.