FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K Number: K870862
·
Decision Mar 24, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
18
Review Days
21
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Basic Information
- Device Name
- SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
- K Number
- K870862
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Atlantic Antibodies
- Date Received
- March 3, 1987
- Decision Date
- March 24, 1987
- 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
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Atlantic Antibodies
| K Number | Device Name | ||
|---|---|---|---|
| K892526 | SPQ TM TEST SYSTEM II FOR CRP | May 9, 1989 | Substantially Equivalent |
| K891154 | SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO B | Mar 16, 1989 | Substantially Equivalent |
| K890563 | SPQ(TM) ANTIBODY REAGENT SET II FOR TRF | Mar 3, 1989 | Substantially Equivalent |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Feb 23, 1989 | Substantially Equivalent |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Feb 22, 1989 | Substantially Equivalent |
| K890416 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGG | Feb 22, 1989 | Substantially Equivalent |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Feb 17, 1989 | Substantially Equivalent |
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Feb 17, 1989 | Substantially Equivalent |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Feb 17, 1989 | Substantially Equivalent |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Feb 15, 1989 | Substantially Equivalent |