FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUEOUS TRIOLEIN STANDARDS & KITS
K Number: K810742
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
24
Review Days
12
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Basic Information
- Device Name
- AQUEOUS TRIOLEIN STANDARDS & KITS
- K Number
- K810742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Supelco, Inc.
- Date Received
- March 19, 1981
- Decision Date
- March 31, 1981
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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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 |
| K883615 | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | Dec 16, 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 |