510(k) K984122
- Device
- WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
- Applicant
- WAKO CHEMICALS, USA, INC.
- 510(k) number
- K984122
- Product code
- JQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-01-20
- Date received
- 1998-11-18
- 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
- TONYA MALLORY
- Address
- 1600 Bellwood Rd. Richmond VA US 23237 23237
FDA Registration Numbers#
- 9681753
- 3002809144
- 3005333358
Source Documents#
Other 510(k) Records For Product Code JQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051111 | SENTINEL UIBC LIQUID | Sentinel Ch. Srl | 2005-11-17 |
| 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#
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