Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
The General Purpose Laboratory Equipment Labeled or Promoted for a Specific Medical Use (product code LXG) encompasses general-purpose laboratory instruments that, when labeled or marketed for a specific medical diagnostic purpose, fall under FDA regulation. Regulated under 21 CFR 862.2050 and classified as a Class 1 device, it is subject to general controls and is GMP-exempt when used as directed. The device falls under the Clinical Chemistry specialty and is reviewed under the Chemistry (CH) panel. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- LXG
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K021927 | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM | Jul 12, 2002 | Substantially Equivalent | Biomet, Inc. |
| K943466 | MINI S.F.T. (URINE PRESERVATIVE) | May 24, 1995 | Substantially Equivalent | Cambridge Diagnostic Products, Inc. |
| K896802 | MAGNET PAD | Dec 27, 1989 | Substantially Equivalent | Westmark, Sterile Packing Systems, Inc. (Sps) |
FEI Numbers
This FDA classification entry is associated with 303 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 304 registration numbers. Click on an entry to view related FDA registrations.