FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K Number: K883615
·
Decision Dec 16, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
10
Applicant Total
24
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
- K Number
- K883615
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Supelco, Inc.
- Date Received
- August 24, 1988
- Decision Date
- December 16, 1988
- 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.
THE CDI(R) SYSTEM 400
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLID PHASE EXTRACTION TUBES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TRISACRYL GF 05 & TRISACRYL GF 2000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HC40/HC75 PREPACKED COLUMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PREFILLED IEC COLUMNS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Supelco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K894141 | LIQUID CHROMATOGRAPHY COLUMNS | Aug 21, 1989 | Substantially Equivalent |
| K884403 | LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE | Dec 22, 1988 | Substantially Equivalent |
| K881868 | LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD | Aug 29, 1988 | Substantially Equivalent |
| K881361 | SOLID PHASE EXTRACTION TUBES | Aug 8, 1988 | Substantially Equivalent |
| K880724 | LIQUID CHROMATO. COLUMNS | May 27, 1988 | Substantially Equivalent |
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Jan 21, 1988 | Substantially Equivalent |
| K871174 | 4-9295 BARBITURATES TEST MIX | Jun 11, 1987 | Substantially Equivalent |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Aug 4, 1986 | Substantially Equivalent |
| K862541 | LIQUID CHROMATOGRAPHY COLUMNS | Jul 29, 1986 | Substantially Equivalent |
| K861633 | LIQUID CHROMATOGRAPHY COLUMNS | May 23, 1986 | Substantially Equivalent |