DIRECTATEX STREP A— 510(k) K861575

Name: FDA 510(k) clearance K861575
Creator: U.S. Food and Drug Administration
Published: 1986-06-03

Substantially Equivalent

Pacific Biotech, Inc.

FDA 510(k) clearance K861575 for DIRECTATEX STREP A, Substantially Equivalent on 1986-06-03. Applicant: Pacific Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Pacific Biotech, Inc.
Product code: Product code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
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 ↗

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K896221 — CARDS O.S.(TM) STREP A1989-12-13
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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.