DeviceClearance

BCS SYSTEM— 510(k) K013114

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K013114 for BCS SYSTEM, Substantially Equivalent on 2001-11-09. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant
Dade Behring, Inc.
Product code
Code JPA
Device class
Class 2
Regulation
21 CFR 864.5425
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JPA

product code JPA
Death
6
Total
6

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 K013114

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 K013114.

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