FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K Number: K991907
·
Decision Nov 9, 1999
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
43
Applicant Total
96
Review Days
155
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Basic Information
- Device Name
- ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K Number
- K991907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5240
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- June 7, 1999
- Decision Date
- November 9, 1999
- Product Code
- CZW
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| CZW | Complement C3, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K Number | Device Name | ||
|---|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | Mar 3, 2003 | Substantially Equivalent |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Feb 11, 2003 | Substantially Equivalent |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Jan 30, 2003 | Substantially Equivalent |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | Jan 23, 2003 | Substantially Equivalent |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent |