FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATININE REAGENT SET
K Number: K844024
·
Decision Oct 30, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
16
Review Days
15
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CREATININE REAGENT SET
- K Number
- K844024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- October 15, 1984
- Decision Date
- October 30, 1984
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGX), ordered by most recent decision date.
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tru Kidney Health Test Panel; Tru Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Creatinine_3 (Crea3)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Creatinine2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
FDA 510(k)
FDA Class 2
·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 |
| K843895 | TOTAL CALCIUM REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K844075 | URIC ACID REAGENT SET | Oct 30, 1984 | Substantially Equivalent |