SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)
FDA 510(k) K911912 · Serono-Baker Diagnostics, Inc.
510(k) numberK911912
Submission
- Device name
- SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase)
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- April 30, 1991
- Decision date
- September 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K970539 | Chiron Diagnostics ACS:180TU PKHQ · Traditional | Chiron Diagnostics Corp. | 03/24/1997SE |
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| K961488 | Elecsys T-Uptake AssayKHQ · Traditional | Boehringer Mannheim Corp. | 06/12/1996SE |
| 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 |
More from Biomerieux Vitek, Inc.
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|---|---|---|
| K924257 | Testosterone Serozyme(Tm) Enzyme ImmunoassayCDZ · Traditional | 11/30/1992SE |
| K915164 | Sri Testosterone Enzyme ImmunoassayCDZ · Traditional | 03/02/1992SE |
| K914886 | Sri(Tm) Cortisol Enzyme Immunoassay(Mag Sol Phase)CGR · Traditional | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | 01/17/1992SE |
| K912937 | SR1 Free T4 Enzyme ImmunoassayCEC · Traditional | 11/19/1991SE |
| K914462 | Sri Progesterone Enzyme Immunoassay(Mag Sold Phas)JLS · Traditional | 10/23/1991SE |
| K911217 | SR1 T4 Enzyme Immunoassay (Magnetic Solid-Phase)KLI · Traditional | 08/16/1991SE |
| K912318 | Estradiol Serozyme Enzyme Immuno (Mag Solid-Phase)CHP · Traditional | 07/25/1991SE |
| K911396 | SR1 Estradiol Enzyme ImmunoassayCHP · Traditional | 05/28/1991SE |
| K910837 | Sri TSH Immunenzymetric AssayJLW · Traditional | 05/24/1991SE |
Questions and answers
When was SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase) cleared by the FDA?
SR1 T3 Uptake Enzyme Immunoassay(Mag Solid-Phase) (K911912) received a 510(k) decision of Substantially Equivalent on September 18, 1991, 141 days after the submission was received.
What is the product code of K911912?
The FDA product code is KHQ – Radioassay, Triiodothyronine Uptake, a Class II (moderate risk) device regulated under 21 CFR 862.1715.