510(k) K872562
- Device
- INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
- Applicant
- INNOTRON OF OREGON, INC.
- 510(k) number
- K872562
- Product code
- LFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-17
- Date received
- 1987-06-24
- Regulation
- 862.3900
- Classification name
- Fluorescence Polarization Immunoassay, Tobramycin
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BUCK, PHD.
- Address
- 4432 Se16th.Ave. Portland OR US 97202 97202
FDA Registration Numbers#
- 3010939897
- 9610126
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | Roche Diagnostic Systems, Inc. | 1997-02-04 |
| K944371 | TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR | Sigma Diagnostics, Inc. | 1994-11-10 |
| K941614 | AXSYM TOBRAMYCIN | Abbott Laboratories | 1994-08-18 |
| K912143 | CEDIA(R) TOBRAMYCIN ASSAY | Microgenics Corp. | 1991-07-26 |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-20 |
| K894531 | FPR TOBRAMYCIN KIT | Colony Laboratories, Inc. | 1989-09-01 |
| K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU | Windsor Laboratories, Inc. | 1985-12-05 |
| K843828 | COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA | Roche Diagnostic Systems, Inc. | 1985-02-01 |
| K841866 | INNOFLOUR TOBRAMYCIN | Innotron Diagnostics | 1984-05-31 |
Legacy Summary#
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FDA Review#
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