510(k) K843827
- Device
- COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K843827
- Product code
- LCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-02-01
- Date received
- 1984-09-28
- Regulation
- 862.3450
- Classification name
- Fluorescent Immunoassay Gentamicin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1220477
- 2050010
- 9610126
- 2050012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972609 | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM | Bio-Rad | 1997-08-06 |
| K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Oxis Intl., Inc. | 1996-02-09 |
| K945523 | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS | Roche Diagnostic Systems, Inc. | 1995-03-09 |
| K943550 | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | 1994-11-17 |
| K905721 | OPUS GENTAMICIN | Pb Diagnostic Systems, Inc. | 1991-02-21 |
| K904226 | 'TDXFLX ANALYZER | Abbott Laboratories | 1990-10-29 |
| K894523 | FPR GENTAMICIN KIT | Colony Laboratories, Inc. | 1989-09-28 |
| K852158 | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA | Bioprobe Intl., Inc. | 1985-06-25 |
| K852013 | GENTAMICIN KIT(FPIA) | Windsor Laboratories, Inc. | 1985-06-10 |
| K841865 | INNOFLOUR GENTAMICIN | Innotron Diagnostics | 1984-05-31 |
| K841162 | IMMPULSE GENTAMICIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 |
| K820285 | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY | Syva Co. | 1982-02-18 |
| K813539 | GENTAMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 |
| K810942 | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | 1981-04-17 |
| K801867 | DISPOSABLE MEDICATION NEBULIZER | Hospitax | 1980-08-20 |
Legacy Summary#
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FDA Review#
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