DeviceClearance

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5— 510(k) K984626

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K984626 for ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5, Substantially Equivalent on 1999-01-29. Applicant: Bio-Rad.

Clearance details

Applicant
Bio-Rad
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.