FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K Number: K860572
·
Decision May 16, 1986
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
74
Review Days
91
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Basic Information
- Device Name
- GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
- K Number
- K860572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Pointe Scientific, Inc.,
- Date Received
- February 14, 1986
- Decision Date
- May 16, 1986
- 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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| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | Oct 7, 2005 | Substantially Equivalent |
| K040391 | TOTAL BILIRUBIN REAGENT SET | Jun 2, 2004 | Substantially Equivalent |
| K031539 | HEMOGLOBIN A1C REAGENT SET | Aug 6, 2003 | Substantially Equivalent |
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