FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINITEK MICROALBUMIN REAGENT STRIPS
K Number: K972706
·
Decision Sep 9, 1997
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
96
Review Days
50
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Basic Information
- Device Name
- CLINITEK MICROALBUMIN REAGENT STRIPS
- K Number
- K972706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- July 21, 1997
- Decision Date
- September 9, 1997
- Product Code
- CJG
- 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 |
|---|---|---|---|
| CJG | Tetrabromo-M-Cresolsulfonphthalein, Albumin | FDA class 2 | Clinical Chemistry |
Other Clearances by Bayer Corp.
| 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 |