FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
K Number: K050182
·
Decision Aug 9, 2005
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
11
Review Days
194
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
- Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
- K Number
- K050182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedix, Inc.
- Date Received
- January 27, 2005
- Decision Date
- August 9, 2005
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGA), ordered by most recent decision date.
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
YSI 2900C Biochemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EasyStat 300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cholestech LDX System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Biomedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | Aug 29, 2014 | Substantially Equivalent |
| K122281 | PADNET 2.0 | Aug 29, 2012 | Substantially Equivalent |
| K073146 | PADNET+ | Nov 21, 2007 | Substantially Equivalent |
| K042616 | BIOMEDIX PADNET LAB | Oct 12, 2004 | Substantially Equivalent |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | May 21, 2004 | Substantially Equivalent |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Dec 29, 1997 | Substantially Equivalent |
| K973644 | FLOSTAT VASCULAR LAB | Dec 23, 1997 | Substantially Equivalent |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 | Sep 16, 1996 | Substantially Equivalent |
| K925645 | SELEC-3 | Sep 27, 1993 | Substantially Equivalent |
| K926498 | ENDOGRIP | Apr 7, 1993 | Substantially Equivalent |