FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BOND ELUT COLUMNS
K Number: K800061
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
2
Review Days
63
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Basic Information
- Device Name
- BOND ELUT COLUMNS
- K Number
- K800061
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Analytichem International, Inc.
- Date Received
- January 9, 1980
- Decision Date
- March 12, 1980
- Product Code
- DJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DJY | Ion-Exchange Chromatography | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DJY), ordered by most recent decision date.
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Other Clearances by Analytichem International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K781728 | EXTUBE | Dec 20, 1978 | Substantially Equivalent |