Cobas FP Reagen for Amikacin & Amikacin Calibrator
FDA 510(k) K852317 · Roche Diagnostic Systems, Inc.
510(k) numberK852317
Submission
- Device name
- Cobas FP Reagen for Amikacin & Amikacin Calibrator
- Applicant
- Roche Diagnostic Systems, Inc.
Nutley, NJ, US - Received
- May 31, 1985
- Decision date
- June 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KLQ – Radioimmunoassay, Amikacin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3035
- Specialty
- Clinical Toxicology
Other 510(k)s with product code KLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | Seradyn, Inc. | 11/01/2005SE |
| K033884 | Randox AmikacinKLQ · Traditional | Randox Laboratories, Ltd. | 06/09/2004SE |
| K955570 | Innofluor Amikacin Assay SystemKLQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K903100 | Innofluor (TM) Amikacin Reagent SetKLQ · Traditional | Innotron of Oregon, Inc. | 08/09/1990SE |
| K894517 | FPR Amikacin KitKLQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K843211 | Amikacin Analytical Test Pack AcaKLQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/12/1984SE |
| K841161 | Immpulse Amikacin Assay ReagentsKLQ · Traditional | Paragon Diagnostics, Inc. | 05/02/1984SE |
| K840193 | Emit QST Amikacin AssayKLQ · Traditional | Syva Co. | 03/23/1984SE |
| K832336 | Stratus Amikacin FluorometricKLQ · Traditional | American Dade | 08/31/1983SE |
| K822657 | Emit-Amd Amikacin AssayKLQ · Traditional | Dade Behring, Inc. | 09/28/1982SE |
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| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Cobas FP Reagen for Amikacin & Amikacin Calibrator cleared by the FDA?
Cobas FP Reagen for Amikacin & Amikacin Calibrator (K852317) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 25 days after the submission was received.
What is the product code of K852317?
The FDA product code is KLQ – Radioimmunoassay, Amikacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.