FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K Number: K061377
·
Decision Mar 28, 2007
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
74
Review Days
315
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Basic Information
- Device Name
- APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- K Number
- K061377
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pointe Scientific, Inc.,
- Date Received
- May 17, 2006
- Decision Date
- March 28, 2007
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| 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.
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IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Pointe Scientific, Inc.,
| K Number | Device Name | ||
|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Dec 4, 2007 | Substantially Equivalent |
| K062118 | POINTE 360 | Jul 13, 2007 | Substantially Equivalent |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Apr 30, 2007 | Substantially Equivalent |
| K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | Apr 13, 2007 | Substantially Equivalent |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | Apr 11, 2007 | Substantially Equivalent |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | Oct 7, 2005 | Substantially Equivalent |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Jun 2, 2004 | Substantially Equivalent |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Aug 6, 2003 | Substantially Equivalent |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | Apr 28, 2003 | Substantially Equivalent |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Mar 31, 2003 | Substantially Equivalent |