SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)— 510(k) K962464
Substantially EquivalentScantibodies Laboratory, Inc.
FDA 510(k) clearance K962464 for SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY), Substantially Equivalent on 1996-10-08. Applicant: Scantibodies Laboratory, Inc.. Device class: 2.
Clearance details
- Applicant
- Scantibodies Laboratory, 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
- Santee, CA, US
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More clearances from Scantibodies Laboratory, Inc.
view all- K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
- K060348 — MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
- K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
- K051810 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
Adverse 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.