FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALTAG CAL-LYSE
K Number: K965232
·
Decision May 14, 1997
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
12
Review Days
134
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Basic Information
- Device Name
- CALTAG CAL-LYSE
- K Number
- K965232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caltag Laboratories, Inc.
- Date Received
- December 31, 1996
- Decision Date
- May 14, 1997
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Caltag Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990641 | CALTAG FETAL HEMOGLOBIN TEST | Sep 17, 1999 | Substantially Equivalent |
| K964856 | CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | Jan 17, 1997 | Substantially Equivalent |
| K963954 | CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY | Nov 25, 1996 | Substantially Equivalent |
| K950918 | CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION | Dec 21, 1995 | Substantially Equivalent |
| K950917 | CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | Dec 21, 1995 | Substantially Equivalent |
| K950916 | CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION | Dec 21, 1995 | Substantially Equivalent |
| K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION | Dec 21, 1995 | Substantially Equivalent |
| K950919 | CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION | Dec 20, 1995 | Substantially Equivalent |
| K944127 | CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY | Jun 20, 1995 | Substantially Equivalent |
| K944128 | CALTAG CD4 R-PE MONOCLONAL ANTIBODY | Jun 20, 1995 | Substantially Equivalent |