FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K Number: K884147
·
Decision Oct 27, 1988
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
28
Review Days
24
Basic Information
- Device Name
- IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
- K Number
- K884147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- ORION DIAGNOSTICA, INC.
- Date Received
- October 3, 1988
- Decision Date
- October 27, 1988
- Product Code
- DFT
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DFT | Igm, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by ORION DIAGNOSTICA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K942286 | DIARLEX ROTA-ADENO | Dec 14, 1994 | Substantially Equivalent |
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| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Oct 27, 1988 | Substantially Equivalent |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Oct 19, 1988 | Substantially Equivalent |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | Oct 19, 1988 | Substantially Equivalent |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Jun 4, 1987 | Substantially Equivalent |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | May 6, 1987 | Substantially Equivalent |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | Sep 16, 1986 | Substantially Equivalent |
| K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS | Jan 21, 1986 | Substantially Equivalent |