TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093— 510(k) K921700
Substantially EquivalentMedix Biotech, Inc.
FDA 510(k) clearance K921700 for TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093, Substantially Equivalent on 1992-06-29. Applicant: Medix Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Medix Biotech, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
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More clearances from Medix Biotech, Inc.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
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.