FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAT TEST HDL/CHOLESTEROL TEST KIT
K Number: K903094
·
Decision Aug 29, 1990
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
4
Review Days
47
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
- STAT TEST HDL/CHOLESTEROL TEST KIT
- K Number
- K903094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Resources, Inc.
- Date Received
- July 13, 1990
- Decision Date
- August 29, 1990
- 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