510(k) K926248
- Device
- READER
- Applicant
- ALAMAR BIOSCIENCES LABORATORY, INC.
- 510(k) number
- K926248
- Product code
- LRH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-17
- Date received
- 1992-12-14
- Regulation
- 866.2660
- Classification name
- Instrument For Auto Reader Of Overnight Microorganism Identification System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL V LANCASTER
- Address
- 4110 N. Fwy. Blvd. Sacramento CA US 95834 95834
FDA Registration Numbers#
- 3009241524
- 1950204
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Biomerieux Vitek, Inc. | 1996-08-30 |
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | Dade Microscan, Inc. | 1996-05-30 |
| K920225 | AUTOSCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-05-22 |
Legacy Summary#
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FDA Review#
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