FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
K Number: K020935
·
Decision Apr 3, 2002
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
9
Review Days
12
Basic Information
- Device Name
- HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706
- K Number
- K020935
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HEMOCUE, INC.
- Date Received
- March 22, 2002
- Decision Date
- April 3, 2002
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | Jun 10, 2004 | Substantially Equivalent |
| K041230 | CLINICAL LABORATORY ANALYZING SYSTEM | May 20, 2004 | Substantially Equivalent |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | Aug 25, 2003 | Substantially Equivalent |
| K962415 | HEMOCUE B-GLCOSE SYSTEM | Oct 15, 1996 | Substantially Equivalent |
| K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM | Sep 24, 1996 | Substantially Equivalent |
| K961311 | HEMOCUE B-GLUCOSE SYSTEM | Aug 23, 1996 | Substantially Equivalent |
| K943432 | HEMOCUE B-GLUCOSE SYSTEM | Jan 17, 1995 | Substantially Equivalent |
| K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER | May 8, 1991 | Substantially Equivalent |