MODIFIED BETA QUIK STAT EIA KIT— 510(k) K882895

Substantially Equivalent

Pacific Biotech, Inc.

FDA 510(k) clearance K882895 for MODIFIED BETA QUIK STAT EIA KIT, Substantially Equivalent on 1988-10-12. Applicant: Pacific Biotech, Inc..

Clearance details

Applicant: Pacific Biotech, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1988-07-11
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.