FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH RANGE PEROXIDE TEST STRIP
K Number: K964264
·
Decision Jun 16, 1997
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
49
Applicant Total
3
Review Days
234
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
- HIGH RANGE PEROXIDE TEST STRIP
- K Number
- K964264
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrated Biomedical Technology, Inc.
- Date Received
- October 25, 1996
- Decision Date
- June 16, 1997
- Product Code
- FKP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKP | System, Dialysate Delivery, Single Patient | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKP), ordered by most recent decision date.
NxStage Connected Health System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NXSTAGE CONNECTED HEALTH SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NXSTAGE DOSING CALCULATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ONEVIEW INTERFACE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRESENIUS ICARE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology