FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K Number: K872852
·
Decision Sep 29, 1987
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
23
Review Days
71
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Basic Information
- Device Name
- EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
- K Number
- K872852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sandare Chemical Co., Inc.
- Date Received
- July 20, 1987
- Decision Date
- September 29, 1987
- 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 Sandare Chemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Aug 8, 1986 | Substantially Equivalent |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | Mar 17, 1986 | Substantially Equivalent |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | May 7, 1985 | Substantially Equivalent |
| K851394 | SANDARE IRON PROCEDURE | Apr 30, 1985 | Substantially Equivalent |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Dec 10, 1984 | Substantially Equivalent |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | Aug 17, 1984 | Substantially Equivalent |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Jan 13, 1984 | Substantially Equivalent |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | Nov 7, 1983 | Substantially Equivalent |
| K832632 | ALBUMIN PROCEDURE BCP | Sep 12, 1983 | Substantially Equivalent |
| K832183 | SANDARE CALCIUM PROCEDURE | Aug 24, 1983 | Substantially Equivalent |