FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URIC ACID DIAGNOSTIC REAGENT
K Number: K801898
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
14
Review Days
63
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
- URIC ACID DIAGNOSTIC REAGENT
- K Number
- K801898
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Connecticut Diagnostics, Ltd.
- Date Received
- August 8, 1980
- Decision Date
- October 10, 1980
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNK), ordered by most recent decision date.
URIC ACID MODEL 3P39
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALAB URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Connecticut Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K905617 | VISI-STAPH | Mar 29, 1991 | Substantially Equivalent |
| K822500 | CDL LYSING REAGENT | Sep 17, 1982 | Substantially Equivalent |
| K822501 | CDL ISOTONIC DILUENT | Sep 17, 1982 | Substantially Equivalent |
| K822504 | CDL AUTO-LYSING REAGENT | Sep 17, 1982 | Substantially Equivalent |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | May 21, 1981 | Substantially Equivalent |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | Oct 10, 1980 | Substantially Equivalent |
| K792465 | CONNECTICUT DIAGNOSTICS, LTS. DIRECT | Dec 18, 1979 | Substantially Equivalent |
| K792338 | DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS | Dec 6, 1979 | Substantially Equivalent |
| K792362 | BLOOD UREA NITROGEN REAGENT | Dec 6, 1979 | Substantially Equivalent |
| K792339 | CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN | Dec 6, 1979 | Substantially Equivalent |