FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K Number: K041133
·
Decision Jul 2, 2004
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
46
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
- MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K Number
- K041133
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- April 30, 2004
- Decision Date
- July 2, 2004
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDD), ordered by most recent decision date.
ARCHITECT Active-B12 (Holotranscobalamin)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIAISON Vitamin B12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Bayer Healthcare, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | Mar 7, 2018 | Substantially Equivalent |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Dec 22, 2015 | Substantially Equivalent |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Jun 23, 2014 | Substantially Equivalent |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | Jul 26, 2012 | Substantially Equivalent |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | Mar 28, 2012 | Substantially Equivalent |
| K093930 | DIDGET WORLD REPORTS | Mar 12, 2010 | Substantially Equivalent |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | Dec 4, 2009 | Substantially Equivalent |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | May 14, 2009 | Substantially Equivalent |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | Oct 8, 2008 | Substantially Equivalent |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Dec 7, 2007 | Substantially Equivalent |