HAEMOPHILUS TEST MEDIUM (HTM)— 510(k) K952595

Name: FDA 510(k) clearance K952595
Creator: U.S. Food and Drug Administration
Published: 1996-04-10

Substantially Equivalent

Clinical Standards Laboratories, Inc.

FDA 510(k) clearance K952595 for HAEMOPHILUS TEST MEDIUM (HTM), Substantially Equivalent on 1996-04-10. Applicant: Clinical Standards Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Standards Laboratories, Inc.
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1995-06-06
Decision date: 1996-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Dominguez, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

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.