Ria Phase TBG
FDA 510(k) K800204 · Boehringer Mannheim Corp.
510(k) numberK800204
Submission
- Device name
- Ria Phase TBG
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- January 30, 1980
- Decision date
- March 19, 1980
- 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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|---|---|---|---|
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| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | Cirrus Diagnostics, Inc. | 04/29/1991SE |
| K905777 | Microzyme Thyroid Uptake Enzyme Immunoassay KitCEE · Traditional | Immunotech Corp. | 01/30/1991SE |
| K900240 | Delfia TBG KitCEE · Traditional | Pharmacia, Inc. | 03/30/1990SE |
| K896991 | Enzymun Test(R) TBKCEE · Traditional | Boehringer Mannheim Corp. | 03/01/1990SE |
| K893469 | Amerlite TBG Assay, LAN.0005/1005 240/144 Test KitCEE · Traditional | Amersham Corp. | 08/15/1989SE |
| K885034 | T-Uptake MicroassayCEE · Traditional | Diamedix Corp. | 02/02/1989SE |
| 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 Ria Phase TBG cleared by the FDA?
Ria Phase TBG (K800204) received a 510(k) decision of Substantially Equivalent on March 19, 1980, 49 days after the submission was received.
What is the product code of K800204?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.