FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOHDL CHOLESTEROL REAGENT SET
K Number: K992002
·
Decision Aug 5, 1999
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
74
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTOHDL CHOLESTEROL REAGENT SET
- K Number
- K992002
- 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 15, 1999
- Decision Date
- August 5, 1999
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBR), ordered by most recent decision date.
LDLC3 LDL-Cholesterol Gen.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
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 |
| 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 |