FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID REAGENT SET
K Number: K844075
·
Decision Oct 30, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
16
Review Days
11
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Basic Information
- Device Name
- URIC ACID REAGENT SET
- K Number
- K844075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- October 19, 1984
- Decision Date
- October 30, 1984
- Product Code
- LFQ
- 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 |
|---|---|---|---|
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFQ), ordered by most recent decision date.
URIC ACID REAGENT SET
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URIC ACID REAGENT SET (COLORIMETRIC)
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SANDARE URIC ACID PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Livonia Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852161 | SERUM IRON/VIBC REAGENT SET | Jun 10, 1985 | Substantially Equivalent |
| K844322 | SGOT REAGENT SET | Nov 27, 1984 | Substantially Equivalent |
| K844283 | SGPT REAGENT SET | Nov 27, 1984 | Substantially Equivalent |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Nov 20, 1984 | Substantially Equivalent |
| K844156 | UREA NITROGEN REAGENT SET | Nov 13, 1984 | Substantially Equivalent |
| K844182 | INORGANIC PHOSPHORUS REAGENT SET | Nov 9, 1984 | Substantially Equivalent |
| K843894 | HDL PRECIPATATING REAGENT SET | Nov 2, 1984 | Substantially Equivalent |
| K843893 | MAGNESIUM REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K844024 | CREATININE REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K843895 | TOTAL CALCIUM REAGENT SET | Oct 30, 1984 | Substantially Equivalent |