FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K Number: K981978
·
Decision Jul 22, 1998
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
30
Applicant Total
74
Review Days
47
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Basic Information
- Device Name
- AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
- K Number
- K981978
- 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
- June 5, 1998
- Decision Date
- July 22, 1998
- Product Code
- MRR
- 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 |
|---|---|---|---|
| MRR | System, Test, Low Density, Lipoprotein | FDA class 1 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | Dec 4, 2007 | Substantially Equivalent |
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| 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 |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Mar 28, 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 |