FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMNISCREEN HOME DETECTION LINER KIT
K Number: K071100
·
Decision Oct 15, 2007
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
10
Applicant Total
2
Review Days
179
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
- AMNISCREEN HOME DETECTION LINER KIT
- K Number
- K071100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1550
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Common Sense , Ltd.
- Date Received
- April 19, 2007
- Decision Date
- October 15, 2007
- Product Code
- CEN
- 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 |
|---|---|---|---|
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEN), ordered by most recent decision date.
VS-SENSE TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AIMSTICK URINE REAGENT STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUICKVUE ADVANCE PH AND AMINES GLL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FEMEXAM TESTCARD
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KYOTEST 5V
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Common Sense , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091287 | VS-SENSE TEST | Aug 31, 2009 | Substantially Equivalent |