Tobramycin Flex Reagent Cartridge
FDA 510(k) K962818 · Dade Intl., Inc.
510(k) numberK962818
Submission
- Device name
- Tobramycin Flex Reagent Cartridge
- Applicant
- Dade Intl., Inc.
Newark, DE, US - Received
- July 19, 1996
- Decision date
- September 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCR – Fluorescent Immunoassay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K060998 | QMS TobramycinLCR · Traditional | Seradyn, Inc. | 07/21/2006SE |
| K974029 | Acs TobramycinLCR · Traditional | Chiron Diagnostics Corp. | 02/12/1998SE |
| K952568 | Beckman Array Tobramycin (Tob) ReagentLCR · Traditional | Beckman Instruments, Inc. | 08/08/1995SE |
| K911940 | Opus(R) TobramycinLCR · Traditional | Pb Diagnostic Systems, Inc. | 07/01/1991SE |
| K911613 | Var Aural Grom AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4LCR · Traditional | Exmoor Plastics , Ltd. | 06/28/1991SE |
| K854873 | Intraocular Pressure ReducerLCR · Traditional | Mira, Inc. | 02/04/1986SE |
| K850058 | Du Pont Tobramycin Assay ReagentsLCR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/18/1985SE |
| K840847 | Immpulse Tobramycin Assay ReagentsLCR · Traditional | Paragon Diagnostics, Inc. | 04/04/1984SE |
| K832408 | Stratus Tobramycin Fluorometric EnzymLCR · Traditional | American Dade | 08/26/1983SE |
| K822197 | Needle HoldersLCR · Traditional | Kelleher Corp. | 08/16/1982SE |
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| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
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| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
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Questions and answers
When was Tobramycin Flex Reagent Cartridge cleared by the FDA?
Tobramycin Flex Reagent Cartridge (K962818) received a 510(k) decision of Substantially Equivalent on September 13, 1996, 56 days after the submission was received.
What is the product code of K962818?
The FDA product code is LCR – Fluorescent Immunoassay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.