FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K Number: K903132
·
Decision Dec 21, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
126
Review Days
157
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Basic Information
- Device Name
- ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
- K Number
- K903132
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ortho Diagnostic Systems, Inc.
- Date Received
- July 17, 1990
- Decision Date
- December 21, 1990
- Product Code
- LJC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Nov 29, 1996 | Substantially Equivalent |
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| 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 |