FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE EXTRACTOR(TM)
K Number: K873932
·
Decision Nov 20, 1987
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
4
Review Days
56
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Basic Information
- Device Name
- THE EXTRACTOR(TM)
- K Number
- K873932
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Molecular Biosystems, Inc.
- Date Received
- September 25, 1987
- Decision Date
- November 20, 1987
- Product Code
- DKO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| DKO | Adsorbents, Ion-Exchange | FDA class 1 | Clinical Chemistry |