Instrument For Auto Reader Of Overnight Microorganism Identification System
This instrument is an automated reader for overnight microorganism identification systems, used in clinical microbiology laboratories to read and process results from overnight bacterial identification panels without manual interpretation. 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 LRH, 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
- LRH
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | May 30, 1996 | Substantially Equivalent | Dade Microscan, Inc. |
| K926248 | READER | May 17, 1994 | Substantially Equivalent | Alamar Biosciences Laboratory, Inc. |
| K920225 | AUTOSCEPTOR IDENTIFICATION SYSTEM | May 22, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.