Coating, Liquid, Glc
The Coating, Liquid, for Gas-Liquid Chromatography (GLC) is a laboratory material used as a stationary phase coating in gas-liquid chromatography columns, enabling the separation of volatile compounds in clinical chemistry applications. It is a Class 1 device subject only to general controls, with no premarket submission required. The product code is DLG, regulated under 21 CFR 862.2250, within the Clinical Chemistry specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- DLG
- Device Class
- FDA class 1
- Regulation Number
- 862.2250
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Apr 06, 2006 | Substantially Equivalent | Lin-Zhi International, Inc. |
| K920419 | IL TEST DAT CAL/CONTROL SET D/E | Mar 11, 1992 | Substantially Equivalent | Instrumentation Laboratory CO |
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Sep 28, 1989 | Substantially Equivalent | Colony Laboratories, Inc. |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Sep 28, 1989 | Substantially Equivalent | Colony Laboratories, Inc. |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Sep 25, 1989 | Substantially Equivalent | Colony Laboratories, Inc. |
| K882766 | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Aug 23, 1988 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | Dec 16, 1983 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.