FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALTAG FETAL HEMOGLOBIN TEST
K Number: K990641
·
Decision Sep 17, 1999
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
12
Review Days
203
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Basic Information
- Device Name
- CALTAG FETAL HEMOGLOBIN TEST
- K Number
- K990641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7455
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Caltag Laboratories, Inc.
- Date Received
- February 26, 1999
- Decision Date
- September 17, 1999
- Product Code
- GHQ
- 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 |
|---|---|---|---|
| GHQ | Stain, Fetal Hemoglobin | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GHQ), ordered by most recent decision date.
View allOther Clearances by Caltag Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K965232 | CALTAG CAL-LYSE | May 14, 1997 | 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 |