FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUSAM TOTAL ALBUMIN ASSAY
K Number: K013643
·
Decision Aug 14, 2003
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
12
Applicant Total
1
Review Days
647
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
- AUSAM TOTAL ALBUMIN ASSAY
- K Number
- K013643
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1645
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ausam Biotecthnologies, Inc.
- Date Received
- November 5, 2001
- Decision Date
- August 14, 2003
- Product Code
- JIQ
- 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 |
|---|---|---|---|
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIQ), ordered by most recent decision date.
TOTAL PROTEIN URINE/CSF GEN.3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEMOCHEK URINE COLLECTION KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URINARY ALBUMIN TEST PACK
FDA 510(k)
FDA Class 1
·Clinical Chemistry