Sentinel Uibc Liquid
FDA 510(k) K051111 · Sentinel Ch. Srl
510(k) numberK051111
Submission
- Device name
- Sentinel Uibc Liquid
- Applicant
- Sentinel Ch. Srl
Milano, IT - Received
- May 2, 2005
- Decision date
- November 17, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQF – Bathophenanthroline, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984122 | Wako L-Type Uibc, Wako Uibc CalibratorJQF · Traditional | Wako Chemicals USA, Inc. | 01/20/1999SE |
| K875176 | Wako(Tm) UibcJQF · Traditional | Wako Chemicals USA, Inc. | 02/02/1988SE |
| K863066 | TransfermeterJQF · Traditional | J. D. Assoc. | 12/04/1986SE |
| K830032 | Total Iron Binding Capacity TestJQF · Traditional | Sclavo, Inc. | 01/28/1983SE |
| K811942 | J & S Iron Saturating ReagentJQF · Traditional | Thyroid Diagnostics, Inc. | 09/08/1981SE |
| K810086 | Iron & TicbJQF · Traditional | Bio-Analytics Laboratories, Inc. | 01/28/1981SE |
| K792409 | Elvi Total Iron Binding CapacityJQF · Traditional | Volu Sol Medical Industries | 12/06/1979SE |
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Questions and answers
When was Sentinel Uibc Liquid cleared by the FDA?
Sentinel Uibc Liquid (K051111) received a 510(k) decision of Substantially Equivalent on November 17, 2005, 199 days after the submission was received.
What is the product code of K051111?
The FDA product code is JQF – Bathophenanthroline, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.