FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K Number: K894031
·
Decision Aug 4, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
19
Applicant Total
505
Review Days
59
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Basic Information
- Device Name
- PHARMASEAL GENETIC AMNIOCENTESIS TRAY
- K Number
- K894031
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Baxter Healthcare Corp
- Date Received
- June 6, 1989
- Decision Date
- August 4, 1989
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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