FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBIN REAGENT
K Number: K823060
·
Decision Nov 22, 1982
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
38
Applicant Total
11
Review Days
35
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Basic Information
- Device Name
- HEMOGLOBIN REAGENT
- K Number
- K823060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Biorent Diagnostic, Inc.
- Date Received
- October 18, 1982
- Decision Date
- November 22, 1982
- Product Code
- KHG
- 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 |
|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | FDA class 2 | Hematology |
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Other Clearances by Biorent Diagnostic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832747 | ALBUMIN REAGENT SET | Oct 14, 1983 | Substantially Equivalent |
| K823211 | CK-UV REAGENT | Nov 22, 1982 | Substantially Equivalent |
| K822494 | OPTIMIZED UV-GPT REAGENT SET | Sep 21, 1982 | Substantially Equivalent |
| K822493 | OPTIMIZED UV-GOT REAGENT SET | Sep 21, 1982 | Substantially Equivalent |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Sep 17, 1982 | Substantially Equivalent |
| K820768 | COLORIMETRIC LDH REAGENT SET | Apr 14, 1982 | Substantially Equivalent |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | Mar 25, 1982 | Substantially Equivalent |
| K813555 | GLUCOSE ENZYME-COLOR REAGENT SET | Jan 18, 1982 | Substantially Equivalent |
| K813244 | UV URIC ACID DETERMINATION | Dec 8, 1981 | Substantially Equivalent |
| K811760 | CHOLESTEROL DETERMINATION | Jul 10, 1981 | Substantially Equivalent |