FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K Number: K983726
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
27
Review Days
34
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Basic Information
- Device Name
- GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
- K Number
- K983726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Corp.
- Date Received
- October 22, 1998
- Decision Date
- November 25, 1998
- Product Code
- LCP
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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