510(k) K972706
- Device
- CLINITEK MICROALBUMIN REAGENT STRIPS
- Applicant
- BAYER CORP.
- 510(k) number
- K972706
- Product code
- CJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-09
- Date received
- 1997-07-21
- Regulation
- 862.1035
- Classification name
- Tetrabromo-m-cresolsulfonphthalein, Albumin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSANNE M SAVOL
- Address
- 1884 Miles Ave. Elkhart IN US 46514 46514
FDA Registration Numbers#
- 3004192065
- 3002637618
- 3008058135
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases