510(k) K052815
- Device
- QMS AMIKACIN REAGENTS
- Applicant
- SERADYN INC.
- 510(k) number
- K052815
- Product code
- KLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-01
- Date received
- 2005-10-04
- 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
- JACK ROGERS
- Address
- 7998 Georgetown Rd. Suite 1000 Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 3010939897
- 3003561301
- 3005333358
- 2517506
- 3004493545
Source Documents#
Other 510(k) Records For Product Code KLQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | 2004-06-09 |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | Oxis Intl., Inc. | 1996-02-09 |
| 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#
summary
FDA Review#
Decision Summary