Coat-A-Count Amikacin Ira
FDA 510(k) K820781 · Diagnostic Products Corp.
510(k) numberK820781
Submission
- Device name
- Coat-A-Count Amikacin Ira
- Applicant
- Diagnostic Products Corp.
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- April 9, 1982
- 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 |
| K852317 | Cobas FP Reagen for Amikacin & Amikacin CalibratorKLQ · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| 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 |
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Questions and answers
When was Coat-A-Count Amikacin Ira cleared by the FDA?
Coat-A-Count Amikacin Ira (K820781) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 17 days after the submission was received.
What is the product code of K820781?
The FDA product code is KLQ – Radioimmunoassay, Amikacin, a Class II (moderate risk) device regulated under 21 CFR 862.3035.