TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005— 510(k) K991311
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K991311 for TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005, Substantially Equivalent on 1999-06-02. Applicant: Biocheck, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocheck, Inc.
- Product code
- Code CDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1710
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
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Adverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.