FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K Number: K023407
·
Decision Feb 14, 2003
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
13
Review Days
127
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Basic Information
- Device Name
- ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
- K Number
- K023407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elan Diagnostics
- Date Received
- October 10, 2002
- Decision Date
- February 14, 2003
- 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 |
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Other Clearances by Elan Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K030003 | ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR | Sep 29, 2003 | Substantially Equivalent |
| K030014 | ATAC TOTAL BILIRUBIN REAGENT | Sep 26, 2003 | Substantially Equivalent |
| K030621 | ATAC CALIBRATOR | Mar 19, 2003 | Substantially Equivalent |
| K023105 | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Mar 13, 2003 | Substantially Equivalent |
| K030010 | ATAC PAK MAGNESIUM REAGENT | Mar 10, 2003 | Substantially Equivalent |
| K030006 | ATAC PAK ALBUMIN REAGENT | Mar 7, 2003 | Substantially Equivalent |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Mar 7, 2003 | Substantially Equivalent |
| K021385 | ATAC PAK BUN REAGENT | Jul 12, 2002 | Substantially Equivalent |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | Apr 12, 2002 | Substantially Equivalent |
| K002285 | ATAC PAK ALP REAGENT KIT | Sep 26, 2000 | Substantially Equivalent |