Gram Negative Identification Panel
The Gram Negative Identification Panel is an in vitro diagnostic device consisting of a panel of biochemical substrates used to identify gram-negative bacteria from clinical cultures based on characteristic metabolic profiles. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQM, regulated under 21 CFR 866.2660, within the Microbiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQM
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- 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 |
|---|---|---|---|---|
| K923313 | ROCHE OXI/FERM II | Apr 05, 1993 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Mar 23, 1993 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K912897 | SCEPTOR IDENTIFICATION SYSTEM | Oct 28, 1991 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Jun 24, 1991 | Substantially Equivalent | Vitek Systems, Inc. |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Jun 09, 1989 | Substantially Equivalent | Radiometer America, Inc. |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | Sep 11, 1986 | Substantially Equivalent | American Micro Scan |
| K851528 | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | Jul 15, 1985 | Substantially Equivalent | Pasco Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.