Advance Diagnostics Disposable Eyecup
FDA 510(k) K881369 · Advantage Diagnostics Corp.
510(k) numberK881369
Submission
- Device name
- Advance Diagnostics Disposable Eyecup
- Applicant
- Advantage Diagnostics Corp.
Tucson, AZ, US - Received
- April 1, 1988
- Decision date
- May 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXQ – Cup, Eye
- Device class
- Unclassified
Other 510(k)s with product code LXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151575 | Dynarex Eye CupsLXQ · Traditional | Dynarex Corporation | 09/01/2015SE |
| K140409 | Flents Plastic Eye Wash CupLXQ · Traditional | Apothecary Products, Inc. | 07/09/2014SE |
| K051414 | Eye Cup, Sterile 1 and Non SterileLXQ · Traditional | Tollot Pty.Ltd.(Aaxis Pacific) | 06/16/2005SE |
| K971134 | Vista EyeshowerLXQ · Traditional | John Branch | 11/04/1997SE |
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| K994227 | Advantage HCG Test (Urine/Serum)JHI · Traditional | 02/03/2000SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | 09/15/1999SE |
| K903416 | Cannula, SurgicalGEA · Traditional | 11/23/1990SE |
Questions and answers
When was Advance Diagnostics Disposable Eyecup cleared by the FDA?
Advance Diagnostics Disposable Eyecup (K881369) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 42 days after the submission was received.
What is the product code of K881369?
The FDA product code is LXQ – Cup, Eye, a Unclassified device.