510(k) K941443
- Device
- SYNERGY QUAD
- Applicant
- REMEL CO.
- 510(k) number
- K941443
- Product code
- JSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-09-19
- Date received
- 1994-03-24
- Regulation
- 866.1700
- Classification name
- Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY A SILVIUS
- Address
- 12076 Santa Fe Dr. Lenexa KS US 66215 66215
FDA Registration Numbers#
- 9615755
- 1111096
- 1119779
- 3013394941
- 8010096
- 3009307598
- 2022807
- 1924669
- 3035708936
- 3009547954
- 8023060
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190553 | HardyCHROM CRE | Hardy Diagnostics | 2019-04-29 |
| K181092 | CHROMID CARBA agar (CARB) | Biomerieux S.A. | 2018-07-06 |
| K171061 | MRSASelect II | Bio-Rad | 2017-12-28 |
| K162620 | Remel Spectra ESBL | Remel, Inc. | 2017-05-01 |
| K160512 | HardyCHROM ESBL | Hardy Diagnostics | 2016-11-15 |
| K162076 | chromID MRSA | bioMerieux, Inc. | 2016-10-25 |
| K151688 | chromID MRSA | bioMerieux, Inc. | 2016-03-11 |
| K122187 | VRESELECT CULTURE MEDIUM | Bio-Rad | 2012-11-06 |
| K103684 | VRESELECT CULTURE MEDIUM | Bio-Rad | 2011-10-21 |
| K102922 | HARDYCHROM MRSA | Hardy Diagnostics | 2011-05-04 |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Bio-Rad | 2010-10-29 |
| K092407 | REMEL SPECTRA MRSA | Remel, Inc. | 2010-10-08 |
| K092767 | BBL CHROMAGAR MRSA II | Becton, Dickinson & CO | 2010-08-20 |
| K092819 | REMEL SPECTRA VRE | Thermo Fisher Scientific | 2010-07-15 |
| K091025 | CHROMID VRE AGAR, MODEL: REF 43 851 | bioMerieux, Inc. | 2010-03-02 |
Legacy Summary#
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FDA Review#
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