FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K Number: K032203
·
Decision Aug 25, 2003
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
9
Review Days
38
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Basic Information
- Device Name
- HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
- K Number
- K032203
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hemocue, Inc.
- Date Received
- July 18, 2003
- Decision Date
- August 25, 2003
- Product Code
- GKR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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Other Clearances by Hemocue, Inc.
| 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 |
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | Apr 3, 2002 | 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 |