FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
MICROALBUMINURIA ASSAY
K Number: K862671
·
Decision Sep 18, 1986
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
36
Applicant Total
21
Review Days
66
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Basic Information
- Device Name
- MICROALBUMINURIA ASSAY
- K Number
- K862671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- July 14, 1986
- Decision Date
- September 18, 1986
- Product Code
- DCF
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Orion Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K912391 | RUBALEX, MODIFICATION | May 4, 1992 | Substantially Equivalent |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Apr 26, 1990 | Substantially Equivalent |
| K884650 | RESUBMITTED SCANORA | Mar 16, 1989 | Substantially Equivalent |
| K890199 | DENTOCULT SM-STRIP MUTANS | Mar 2, 1989 | Substantially Equivalent |
| K881506 | MAMEX DC MAG MG12 | Jun 10, 1988 | Substantially Equivalent |
| K881505 | MAMEX DC MG11 | Jun 10, 1988 | Substantially Equivalent |
| K874040 | MAMEX DC S SL10/MG14 | Nov 23, 1987 | Substantially Equivalent |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Sep 22, 1987 | Substantially Equivalent |
| K872301 | DENTOCULT-SM CULTURE-PADDLE | Sep 11, 1987 | Substantially Equivalent |
| K864457 | CHLAMYSET ANTIBODY EIA | Sep 11, 1987 | Substantially Equivalent |