FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN REAGENT SET
K Number: K843701
·
Decision Oct 1, 1984
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
16
Review Days
10
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Basic Information
- Device Name
- TOTAL PROTEIN REAGENT SET
- K Number
- K843701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- September 21, 1984
- Decision Date
- October 1, 1984
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
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STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
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·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 |