Tobramycin Reagent Test Kit
FDA 510(k) K813391 · Beckman Instruments, Inc.
510(k) numberK813391
Submission
- Device name
- Tobramycin Reagent Test Kit
- Applicant
- Beckman Instruments, Inc.
Walker, MI, US - Received
- December 3, 1981
- Decision date
- December 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKB – Pad, Alcohol, Device Disinfectant
- Device class
- Unclassified
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| K910735 | Hexidis Alcohol SwabLKB · Traditional | Specialites Septodont | 04/02/1991SE |
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | Bowen & Company, Inc. | 04/04/1990SE |
| K896835 | Alcohol Prep and Povidone-Iodine PrepLKB · Traditional | Norpak Mfg., Inc. | 01/11/1990SE |
| K894791 | Baxter Acetone-Alcohol Swabstick, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K893958 | Baxter Acetone-Alcohol Prep Pads, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
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Questions and answers
When was Tobramycin Reagent Test Kit cleared by the FDA?
Tobramycin Reagent Test Kit (K813391) received a 510(k) decision of Substantially Equivalent on December 18, 1981, 15 days after the submission was received.
What is the product code of K813391?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.