The Autolet Lite
FDA 510(k) K894474 · Ulster Scientific, Inc.
Submission
- Device name
- The Autolet Lite
- Applicant
- Ulster Scientific, Inc.
Highland, NY, US - Received
- July 18, 1989
- Decision date
- August 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable…
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| K871571 | Neurotips(Tm)GXB · Traditional | 06/18/1987SE |
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Questions and answers
When was The Autolet Lite cleared by the FDA?
The Autolet Lite (K894474) received a 510(k) decision of Substantially Equivalent on August 18, 1989, 31 days after the submission was received.
What is the product code of K894474?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.