FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO HSV ANTIGEN ELISA TEST
K Number: K915551
·
Decision Apr 22, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
37
Applicant Total
126
Review Days
133
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
- ORTHO HSV ANTIGEN ELISA TEST
- K Number
- K915551
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Diagnostic Systems, Inc.
- Date Received
- December 11, 1991
- Decision Date
- April 22, 1992
- Product Code
- LGC
- 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 |
|---|---|---|---|
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGC), ordered by most recent decision date.
HERPES GROUP IGG
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
FDA 510(k)
FDA Class 2
·Microbiology
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
FDA 510(k)
FDA Class 2
·Microbiology
POCKIT HSV 2 RAPID TEST
FDA 510(k)
FDA Class 2
·Microbiology
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 |