AIA-PACK TSH 3RD-GEN ASSAY— 510(k) K972586
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K972586 for AIA-PACK TSH 3RD-GEN ASSAY, Substantially Equivalent on 1997-08-29. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, 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 Tosoh Medics, 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 →
Recalls naming K972586
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972586.
Data sourced from openFDA. This site is unofficial and independent of the FDA.