FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K Number: K811567
·
Decision Sep 16, 1981
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
126
Review Days
104
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Basic Information
- Device Name
- ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
- K Number
- K811567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Ortho Diagnostic Systems, Inc.
- Date Received
- June 4, 1981
- Decision Date
- September 16, 1981
- Product Code
- LCP
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Ortho Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | Jul 14, 1997 | Substantially Equivalent |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | Mar 6, 1997 | Substantially Equivalent |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | Jan 22, 1997 | Substantially Equivalent |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Nov 29, 1996 | Substantially Equivalent |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | May 13, 1996 | Substantially Equivalent |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | May 13, 1996 | Substantially Equivalent |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | May 13, 1996 | Substantially Equivalent |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | May 10, 1996 | Substantially Equivalent |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | May 9, 1996 | Substantially Equivalent |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | Apr 30, 1996 | Substantially Equivalent |