510(k) K875176
- Device
- WAKO(TM) UIBC
- Applicant
- WAKO CHEMICALS, USA, INC.
- 510(k) number
- K875176
- Product code
- JQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-02
- Date received
- 1987-12-17
- Regulation
- 862.1415
- Classification name
- Bathophenanthroline, Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOSHIHIKO ODA
- Address
- 12300 Ford Rd. Suite 130 Dallas TX US 75234 75234
FDA Registration Numbers#
- 9681753
- 3002809144
- 3005333358
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051111 | SENTINEL UIBC LIQUID | Sentinel Ch. Srl | 2005-11-17 |
| K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Wako Chemicals USA, Inc. | 1999-01-20 |
| 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#
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FDA Review#
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