FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
K Number: K965022
·
Decision Nov 6, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
52
Applicant Total
54
Review Days
325
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
- K Number
- K965022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dako Corp.
- Date Received
- December 16, 1996
- Decision Date
- November 6, 1997
- Product Code
- DEH
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DEH | Lambda, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEH), ordered by most recent decision date.
VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k)
FDA Class 2
·Immunology
FREELITE HUMAN LAMBDA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
LAMBDA LIGHT CHAINS
FDA 510(k)
FDA Class 2
·Immunology
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
FDA 510(k)
FDA Class 2
·Immunology
FREELITE HUMAN LAMBDA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Dako Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | Feb 28, 2002 | Substantially Equivalent |
| 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 |
| 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 |
| K960531 | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE | Jun 14, 1996 | Substantially Equivalent |