Product Code: DII
FDA class 1
21 CFR 862.2250
Columns, Glc
Clinical Chemistry
GLC Columns are gas-liquid chromatography columns used as laboratory instruments for separating and quantifying chemical compounds in biological specimens, supporting a range of clinical chemistry analyses including drug and metabolite quantification. This device is classified as FDA Class 1, indicating low risk, requiring only general controls and no premarket notification. It is regulated under 21 CFR 862.2250 within the Clinical Chemistry specialty.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
8
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Basic Information
- Product Code
- DII
- Device Class
- FDA class 1
- Regulation Number
- 862.2250
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Jan 21, 1988 | Substantially Equivalent | Supelco, Inc. |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Aug 04, 1986 | Substantially Equivalent | Supelco, Inc. |
| K844164 | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | Dec 10, 1984 | Substantially Equivalent | Lkb Instruments, Inc. |
| K841712 | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | May 21, 1984 | Substantially Equivalent | Supelco, Inc. |
| K791893 | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | Oct 30, 1979 | Substantially Equivalent | Hewlett-Packard Co. |