Transfermeter
FDA 510(k) K863066 · J. D. Assoc.
510(k) numberK863066
Submission
- Device name
- Transfermeter
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 12, 1986
- Decision date
- December 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K051111 | Sentinel Uibc LiquidJQF · Traditional | Sentinel Ch. Srl | 11/17/2005SE |
| 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 |
| 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 |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
| K863056 | Bilirubin TotalCIG · Traditional | 11/24/1986SE |
Questions and answers
When was Transfermeter cleared by the FDA?
Transfermeter (K863066) received a 510(k) decision of Substantially Equivalent on December 4, 1986, 114 days after the submission was received.
What is the product code of K863066?
The FDA product code is JQF – Bathophenanthroline, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.