510(k) K926002
- Device
- ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
- Applicant
- ALAMAR BIOSCIENCES LABORATORY, INC.
- 510(k) number
- K926002
- Product code
- JSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-23
- Date received
- 1992-11-27
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Enterobacteriaceae
- 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#
- 9615755
- 9680577
- 3009171251
- 9615754
- 1924669
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150031 | hemoFISH Masterpanel | Miacom Diagnostics GmbH | 2015-10-01 |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Advandx, Inc. | 2013-07-21 |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2010-12-16 |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-12-16 |
| K092393 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-09-01 |
| K082068 | E. COLI PNA FISH | Advandx, Inc. | 2009-06-25 |
| K081433 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-03-26 |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2008-12-19 |
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 |
| K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | Becton Dickinson Microbiology Systems | 1993-03-11 |
| K924814 | API 20E/UNISCEPT 20E | Analytical Products, Inc. | 1993-03-11 |
| K922588 | ROCHE ENTEROTUBE II | Roche Diagnostic Systems, Inc. | 1992-09-11 |
| K912924 | RAMBACH AGAR | Rantran, Inc. | 1992-02-28 |
| K894776 | SENSITITRE INDOLE REAGENT | Radiometer America, Inc. | 1989-08-31 |
| K890626 | RAPIDEC COLI | Dms Products, Inc. | 1989-06-02 |
Legacy Summary#
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FDA Review#
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