FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KING DIAGNOSTICS PHOSPHORUS TEST
K Number: K811749
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
41
Review Days
18
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Basic Information
- Device Name
- KING DIAGNOSTICS PHOSPHORUS TEST
- K Number
- K811749
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- King Diagnostics, Inc.
- Date Received
- June 22, 1981
- Decision Date
- July 10, 1981
- Product Code
- CEO
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
FDA 510(k)
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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 |