510(k) K051111
- Device
- SENTINEL UIBC LIQUID
- Applicant
- SENTINEL CH. SRL
- 510(k) number
- K051111
- Product code
- JQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-17
- Date received
- 2005-05-02
- Regulation
- 862.1415
- Classification name
- Bathophenanthroline, Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVIDE SPADA
- Address
- 5 Via Principe Eugenio Milano IT 20155 20155
FDA Registration Numbers#
- 9681753
- 3002809144
- 3005333358
Source Documents#
Other 510(k) Records For Product Code JQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Wako Chemicals USA, Inc. | 1999-01-20 |
| K875176 | WAKO(TM) UIBC | Wako Chemicals USA, Inc. | 1988-02-02 |
| K863066 | TRANSFERMETER | J. D. Assoc. | 1986-12-04 |
| K830032 | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | 1983-01-28 |
| K811942 | J & S IRON SATURATING REAGENT | Thyroid Diagnostics, Inc. | 1981-09-08 |
| K810086 | IRON & TICB | Bio-Analytics Laboratories, Inc. | 1981-01-28 |
| K792409 | ELVI TOTAL IRON BINDING CAPACITY | Volu Sol Medical Industries | 1979-12-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary