FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K Number: K974721
·
Decision Mar 3, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
96
Review Days
75
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Basic Information
- Device Name
- UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K Number
- K974721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- December 18, 1997
- Decision Date
- March 3, 1998
- Product Code
- CGI
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
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