CALTAG CAL-LYSE— 510(k) K965232
Substantially EquivalentCaltag Laboratories, Inc.
FDA 510(k) clearance K965232 for CALTAG CAL-LYSE, Substantially Equivalent on 1997-05-14. Applicant: Caltag Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Caltag Laboratories, Inc.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dowingtown, PA, US
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- K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
- K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
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.