FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇮 Finland
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K Number: K861882
·
Decision Oct 29, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
21
Review Days
167
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Basic Information
- Device Name
- IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
- K Number
- K861882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Orion Corp.
- Date Received
- May 15, 1986
- Decision Date
- October 29, 1986
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
DIAZYME APOLIPOPROTEIN A-1 ASSAY
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DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
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8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
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SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
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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 |