FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATAC PAK BUN REAGENT
K Number: K021385
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
13
Review Days
71
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
- ATAC PAK BUN REAGENT
- K Number
- K021385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elan Diagnostics
- Date Received
- May 2, 2002
- Decision Date
- July 12, 2002
- Product Code
- CDQ
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDQ), ordered by most recent decision date.
Urea Nitrogen2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYRA UREA NITROGEN AND CREATININE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA/BUN, SCAL, NORTROL, ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | Feb 14, 2003 | 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 |