SERACON CR REFERENCE— 510(k) K904503

Substantially Equivalent

Bhp Diagnostix, Inc.

FDA 510(k) clearance K904503 for SERACON CR REFERENCE, Substantially Equivalent on 1990-11-02. Applicant: Bhp Diagnostix, Inc..

Clearance details

Applicant: Bhp Diagnostix, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1990-10-02
Decision date: 1990-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.