510(k) K955570
- Device
- INNOFLUOR AMIKACIN ASSAY SYSTEM
- Applicant
- OXIS INTL., INC.
- 510(k) number
- K955570
- Product code
- KLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-02-09
- Date received
- 1995-12-06
- Regulation
- 862.3035
- Classification name
- Radioimmunoassay, Amikacin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNDA M TAYLOR
- Address
- 6040 N. Cutter Cir., #317 Portland OR US 97217 97217
FDA Registration Numbers#
- 3004493545
- 3010939897
- 2517506
- 3005333358
- 3003561301
Source Documents#
Other 510(k) Records For Product Code KLQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052815 | QMS AMIKACIN REAGENTS | Seradyn, Inc. | 2005-11-01 |
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | 2004-06-09 |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Innotron of Oregon, Inc. | 1990-08-09 |
| K894517 | FPR AMIKACIN KIT | Colony Laboratories, Inc. | 1989-09-28 |
| K852317 | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| K843211 | AMIKACIN ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | 1984-09-12 |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 |
| K840193 | EMIT QST AMIKACIN ASSAY | Syva Co. | 1984-03-23 |
| K832336 | STRATUS AMIKACIN FLUOROMETRIC | American Dade | 1983-08-31 |
| K822657 | EMIT-AMD AMIKACIN ASSAY | Dade Behring, Inc. | 1982-09-28 |
| K821771 | MACRO-VUE CARD TEST, AMIKACIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 |
| K820781 | COAT-A-COUNT AMIKACIN IRA | Diagnostic Products Corp. | 1982-04-09 |
| K813541 | AMIKACIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 |
| K811026 | AMES TDA TM AMIKACIN TEST | Miles Laboratories, Inc. | 1981-04-29 |
| K802877 | AMIKACIN RIA KIT | Antibodies, Inc. | 1980-12-19 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases