FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
K Number: K960887
·
Decision May 17, 1996
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
54
Review Days
74
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Basic Information
- Device Name
- MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
- K Number
- K960887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dako Corp.
- Date Received
- March 4, 1996
- Decision Date
- May 17, 1996
- 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 Dako Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | Mar 3, 2000 | Substantially Equivalent |
| K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | Jun 21, 1999 | Substantially Equivalent |
| K991454 | MOUSE IGG1 NEGATIVE CONTROLS | Jun 21, 1999 | Substantially Equivalent |
| K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | Jul 22, 1998 | Substantially Equivalent |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dec 12, 1997 | Substantially Equivalent |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Nov 6, 1997 | Substantially Equivalent |
| K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | Jun 24, 1997 | Substantially Equivalent |
| K961701 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE | Jul 16, 1996 | Substantially Equivalent |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | Jul 5, 1996 | Substantially Equivalent |