FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDXR FETAL LUNG MATURITY
K Number: K871593
·
Decision Jul 20, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
857
Review Days
87
Basic Information
- Device Name
- TDXR FETAL LUNG MATURITY
- K Number
- K871593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1455
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- April 24, 1987
- Decision Date
- July 20, 1987
- Product Code
- JHG
- 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 |
|---|---|---|---|
| JHG | Chromatographic Separation, Lecithin/Sphingomyelin Ratio | FDA class 2 | Clinical Chemistry |
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