FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K Number: K031044
·
Decision Jul 15, 2003
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
117
Applicant Total
36
Review Days
105
Basic Information
- Device Name
- ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
- K Number
- K031044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CLINICAL DATA, INC.
- Date Received
- April 1, 2003
- Decision Date
- July 15, 2003
- Product Code
- KNK
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
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Other Clearances by CLINICAL DATA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K071706 | ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) | Dec 20, 2007 | Substantially Equivalent |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Feb 9, 2006 | Substantially Equivalent |
| K033983 | VITALAB IRON REAGENT | May 21, 2004 | Substantially Equivalent |
| K040631 | VITALAB DIRECT BILIRUBIN REAGENT | Mar 18, 2004 | Substantially Equivalent |
| K040534 | VITALAB AMYLASE REAGENT | Mar 11, 2004 | Substantially Equivalent |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Mar 10, 2004 | Substantially Equivalent |
| K040508 | VITALAB MAGNESIUM REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K040467 | VITALAB URIC ACID REAGENT | Mar 8, 2004 | Substantially Equivalent |
| K031042 | ATAC HEMOGLOBIN A1C REAGENT KIT | Nov 3, 2003 | Substantially Equivalent |
| K863904 | DISPOSABLE ECG MONITORING ELECTRODE | Jan 6, 1987 | Substantially Equivalent |