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

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..

Clearance details

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

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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.