FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URINARY 17-KETOSTERIOD/17
K Number: K772337
·
Decision Jan 12, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- URINARY 17-KETOSTERIOD/17
- K Number
- K772337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1385
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Eppendorf-Brinkmann, Inc.
- Date Received
- December 22, 1977
- Decision Date
- January 12, 1978
- Product Code
- CDG
- 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 |
|---|---|---|---|
| CDG | Chromatography Separation/Zimmerman 17-Ketogenic Steroids | FDA class 1 | Clinical Chemistry |