Tri-Tube Ria
FDA 510(k) K840589 · Nuclear Medical Laboratories, Inc.
510(k) numberK840589
Submission
- Device name
- Tri-Tube Ria
- Applicant
- Nuclear Medical Laboratories, Inc.
Mchenry, IL, US - Received
- February 9, 1984
- Decision date
- March 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHQ – Radioassay, Triiodothyronine Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1715
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | Chiron Diagnostics Corp. | 03/24/1997SE |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 11/27/1996SE |
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| K954807 | Cedia T Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 12/21/1995SE |
| K951586 | T-Uptake Eia TestKHQ · Traditional | Diagnostic Reagents, Inc. | 05/15/1995SE |
| K933414 | Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional | Baxter Diagnostics, Inc. | 11/22/1994SE |
| K934312 | Axsym(Tm) T-UptakeKHQ · Traditional | Abbott Laboratories | 06/21/1994SE |
| K935816 | Vidas T UptakeKHQ · Traditional | Biomerieux Vitek, Inc. | 03/22/1994SE |
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| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K822298 | Diagnostic Radioimmunoassay for QuantiJFH · Traditional | 09/02/1982SE |
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| K812759 | NML Ck-Mb RiaJHX · Traditional | 10/19/1981SE |
Questions and answers
When was Tri-Tube Ria cleared by the FDA?
Tri-Tube Ria (K840589) received a 510(k) decision of Substantially Equivalent on March 9, 1984, 29 days after the submission was received.
What is the product code of K840589?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.