Reader
FDA 510(k) K926248 · Alamar Biosciences Laboratory, Inc.
510(k) numberK926248
Submission
- Device name
- Reader
- Applicant
- Alamar Biosciences Laboratory, Inc.
Sacramento, CA, US - Received
- December 14, 1992
- Decision date
- May 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRH – Instrument For Auto Reader Of Overnight Microorganism Identification System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | Biomerieux Vitek, Inc. | 08/30/1996SE |
| K961042 | Microscan Rapid Gram-Negative Indentification Type 3 PanelLRH · Traditional | Dade Microscan, Inc. | 05/30/1996SE |
| K920225 | Autosceptor Identification SystemLRH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/22/1992SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K941425 | Alamar Antibiotic SusceptibilityLRG · Traditional | 12/15/1994SE |
| K926002 | Alamar Bacterial Identification Test PanelJSS · Traditional | 09/23/1993SE |
| K925951 | ReadarLRG · Traditional | 08/31/1993SE |
| K930469 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 06/25/1993SE |
| K930055 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 04/05/1993SE |
| K924500 | Antimicrobial Susceptibility TestJWY · Traditional | 11/30/1992SE |
| K922780 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 08/20/1992SE |
| K922003 | Antimicrobial Suscetibility Test PanelJWY · Traditional | 08/19/1992SE |
| K922168 | Antimicrobial Susceptibility Test PanelJWY · Traditional | 07/28/1992SE |
| K911558 | Antimicrobial Suscept. Test Panel NitrofurantoinJWY · Traditional | 05/15/1991SE |
Questions and answers
When was Reader cleared by the FDA?
Reader (K926248) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 519 days after the submission was received.
What is the product code of K926248?
The FDA product code is LRH – Instrument For Auto Reader Of Overnight Microorganism Identification System, a Class I (low risk) device regulated under 21 CFR 866.2660.