Iron & Ticb
FDA 510(k) K810086 · Bio-Analytics Laboratories, Inc.
510(k) numberK810086
Submission
- Device name
- Iron & Ticb
- Applicant
- Bio-Analytics Laboratories, Inc.
Mchenry, IL, US - Received
- January 13, 1981
- Decision date
- January 28, 1981
- 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
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| 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 |
| K792409 | Elvi Total Iron Binding CapacityJQF · Traditional | Volu Sol Medical Industries | 12/06/1979SE |
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| K851514 | Ultra-Violet Glucose ReagentCFA · Traditional | 05/20/1985SE |
| K851513 | Ultra-Violet Bun Reagent KitCDQ · Traditional | 05/20/1985SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | 03/05/1985SE |
| K832771 | Erythrocyte TestLKZ · Traditional | 10/28/1983SE |
| K832567 | Acetaminophen(ParacetamolLDP · Traditional | 09/12/1983SE |
| K831414 | Colorimetric BunCDL · Traditional | 06/16/1983SE |
| K821934 | Bio-Cal Operation Check KitJIS · Traditional | 07/20/1982SE |
Questions and answers
When was Iron & Ticb cleared by the FDA?
Iron & Ticb (K810086) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 15 days after the submission was received.
What is the product code of K810086?
The FDA product code is JQF – Bathophenanthroline, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.