FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN VITRO DIAGNOSTIC STANDARDS
K Number: K802278
·
Decision Nov 24, 1980
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
24
Review Days
73
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Basic Information
- Device Name
- IN VITRO DIAGNOSTIC STANDARDS
- K Number
- K802278
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Supelco, Inc.
- Date Received
- September 12, 1980
- Decision Date
- November 24, 1980
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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·Clinical Toxicology
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 |