LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System Class I
FDA product code LRH covers "Instrument For Auto Reader Of Overnight Microorganism Identification System", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LRH
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962609 | biomerieux vitek | GRAM NEGATIVE IDENTIFICATION PLUS CARD | August 30, 1996 |
| K961042 | dade microscan | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | May 30, 1996 |
| K926248 | alamar biosciences laboratory | READER | May 17, 1994 |
| K920225 | bd becton dickinson vacutainer systems preanalytic | AUTOSCEPTOR IDENTIFICATION SYSTEM | May 22, 1992 |