H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER— 510(k) K883177
Substantially EquivalentTexas Intl. Laboratories, Inc.
FDA 510(k) clearance K883177 for H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER, Substantially Equivalent on 1988-11-30. Applicant: Texas Intl. Laboratories, Inc..
Clearance details
- Applicant
- Texas Intl. Laboratories, Inc.
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . 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.