SR1 Free T4 Enzyme Immunoassay
FDA 510(k) K912937 · Serono-Baker Diagnostics, Inc.
510(k) numberK912937
Submission
- Device name
- SR1 Free T4 Enzyme Immunoassay
- Applicant
- Serono-Baker Diagnostics, Inc.
Allentown, PA, US - Received
- July 5, 1991
- Decision date
- November 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| 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 |
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Questions and answers
When was SR1 Free T4 Enzyme Immunoassay cleared by the FDA?
SR1 Free T4 Enzyme Immunoassay (K912937) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 137 days after the submission was received.
What is the product code of K912937?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.