FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLYCO-CHECK
K Number: K852111
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
2
Review Days
51
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Basic Information
- Device Name
- GLYCO-CHECK
- K Number
- K852111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Thyroid Diagnostics, Inc.
- Date Received
- May 15, 1985
- Decision Date
- July 5, 1985
- Product Code
- LCP
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Thyroid Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811942 | J & S IRON SATURATING REAGENT | Sep 8, 1981 | Substantially Equivalent |