T-Uptake Microassay
FDA 510(k) K885034 · Diamedix Corp.
510(k) numberK885034
Submission
- Device name
- T-Uptake Microassay
- Applicant
- Diamedix Corp.
Miami, FL, US - Received
- December 5, 1988
- Decision date
- February 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEE – Radioimmunoassay, Thyroxine-Binding Globulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1685
- Specialty
- Clinical Chemistry
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| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | Cyberfluor, Inc. | 12/14/1988SE |
| K874658 | Technicon Ra(R) Analyte (TBG) (30 C and 37 C)CEE · Traditional | Technicon Instruments Corp. | 12/18/1987SE |
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Questions and answers
When was T-Uptake Microassay cleared by the FDA?
T-Uptake Microassay (K885034) received a 510(k) decision of Substantially Equivalent on February 2, 1989, 59 days after the submission was received.
What is the product code of K885034?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.