DIRECTATEX STREP A— 510(k) K861575

Substantially Equivalent

Pacific Biotech, Inc.

FDA 510(k) clearance K861575 for DIRECTATEX STREP A, Substantially Equivalent on 1986-06-03. Applicant: Pacific Biotech, Inc..

Clearance details

Applicant: Pacific Biotech, Inc.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1986-04-28
Decision date: 1986-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GTY

product code GTY

Death: 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.