LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Class I
FDA product code LXG covers "Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXG
- Device Class
- Class I
- Regulation Number
- 862.2050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021927 | biomet | PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM | July 12, 2002 |
| K943466 | cambridge diagnostic products | MINI S.F.T. (URINE PRESERVATIVE) | May 24, 1995 |
| K896802 | westmark, sterile packing systems, inc. (sps) | MAGNET PAD | December 27, 1989 |