FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KING DIAGNOSTICS HEMOGLOBIN TEST
K Number: K812127
·
Decision Aug 25, 1981
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
41
Review Days
29
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Basic Information
- Device Name
- KING DIAGNOSTICS HEMOGLOBIN TEST
- K Number
- K812127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- King Diagnostics, Inc.
- Date Received
- July 27, 1981
- Decision Date
- August 25, 1981
- Product Code
- GKR
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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Other Clearances by King Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933329 | KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT | Oct 22, 1993 | Substantially Equivalent |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | Aug 25, 1993 | Substantially Equivalent |
| K931773 | HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) | Aug 16, 1993 | Substantially Equivalent |
| K931326 | KING DIAGNOSTICS CK REAGENT | Jun 15, 1993 | Substantially Equivalent |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | Nov 2, 1992 | Substantially Equivalent |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 | Substantially Equivalent |
| K922921 | KING DIAGNOSTICS CHLORIDE REAGENT | Oct 5, 1992 | Substantially Equivalent |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | Sep 30, 1992 | Substantially Equivalent |
| K923091 | KING DIAGNOSTICS GAMMA GT REAGENT | Sep 9, 1992 | Substantially Equivalent |
| K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT | Sep 9, 1992 | Substantially Equivalent |