FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OT IGG SORBENT
K Number: K934324
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
75
Applicant Total
130
Review Days
230
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Basic Information
- Device Name
- OT IGG SORBENT
- K Number
- K934324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organon Teknika Corp.
- Date Received
- September 3, 1993
- Decision Date
- April 21, 1994
- Product Code
- DEW
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEW), ordered by most recent decision date.
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ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
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SPIFE IFE CALIBRATOR AND CONTROL KIT
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WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
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K-ASSAY IGG
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IGG
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Organon Teknika Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K003104 | BACT/ALERT CSR | Oct 20, 2000 | Substantially Equivalent |
| K000492 | MDA D-DIMER | Jun 7, 2000 | Substantially Equivalent |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Mar 2, 2000 | Substantially Equivalent |
| K994343 | BACT/ALERT SV | Feb 10, 2000 | Substantially Equivalent |
| K993423 | BACT/ALERT SA | Dec 15, 1999 | Substantially Equivalent |
| K993421 | BACT/ALERT SN | Dec 14, 1999 | Substantially Equivalent |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Dec 14, 1999 | Substantially Equivalent |
| K992432 | BACT/ALERT FN | Sep 24, 1999 | Substantially Equivalent |
| K983762 | NUCLISENS CMV PP67 | Sep 15, 1999 | Substantially Equivalent |
| K992401 | BACT/ALERT PF | Sep 3, 1999 | Substantially Equivalent |