FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
K Number: K944195
·
Decision Mar 23, 1995
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
15
Review Days
206
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Basic Information
- Device Name
- QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
- K Number
- K944195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medisense, Inc.
- Date Received
- August 29, 1994
- Decision Date
- March 23, 1995
- 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 |
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Other Clearances by Medisense, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983504 | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | Jul 9, 1999 | Substantially Equivalent |
| K982303 | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | Dec 8, 1998 | Substantially Equivalent |
| K983253 | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | Nov 20, 1998 | Substantially Equivalent |
| K971812 | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | Aug 8, 1997 | Substantially Equivalent |
| K963676 | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | Feb 20, 1997 | Substantially Equivalent |
| K962295 | PRECISION QID BLOOD GLUCOSE TEST STRIP | Jul 26, 1996 | Substantially Equivalent |
| K961337 | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | Jun 21, 1996 | Substantially Equivalent |
| K952279 | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM | Jun 14, 1995 | Substantially Equivalent |
| K945887 | PRECISION Q I D BLOOD GLUCOSE TEST STRIPS | Mar 23, 1995 | Substantially Equivalent |
| K901613 | MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM | Jul 10, 1990 | Substantially Equivalent |