DeviceClearance

AIA-PACK CTNI 2ND-GEN ASSAY— 510(k) K012820

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K012820 for AIA-PACK CTNI 2ND-GEN ASSAY, Substantially Equivalent on 2001-12-14. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant
Tosoh Medics, Inc.
Product code
Code MMI
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MMI

product code MMI
Injury
172
Malfunction
3,762
Total
3,934

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 K012820

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012820.

Data sourced from openFDA. This site is unofficial and independent of the FDA.