RDW AND MPV INDICES ON HEMAT 12— 510(k) K900684

Name: FDA 510(k) clearance K900684
Creator: U.S. Food and Drug Administration
Published: 1990-04-16

Substantially Equivalent

Texas Intl. Laboratories, Inc.

FDA 510(k) clearance K900684 for RDW AND MPV INDICES ON HEMAT 12, Substantially Equivalent on 1990-04-16. Applicant: Texas Intl. Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Texas Intl. Laboratories, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1990-02-12
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.