TBG Ria
FDA 510(k) K842167 · Syncor Intl. Corp.
510(k) numberK842167
Submission
- Device name
- TBG Ria
- Applicant
- Syncor Intl. Corp.
Mchenry, IL, US - Received
- May 31, 1984
- Decision date
- July 9, 1984
- 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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|---|---|---|---|
| K952284 | Amerlite TBG AssayCEE · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 07/26/1995SE |
| K930010 | Access Thyroid Uptake AssayCEE · Traditional | Bio-Rad Laboratories, Inc. | 06/07/1993SE |
| 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 |
More from Technicon Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
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| K852023 | Cesium 137 Source, CSM-4, CSM-11, CSM-41KXK · Traditional | 08/21/1985SE |
| K850433 | Cesium 137 Endometrial SourceKXK · Traditional | 08/21/1985SE |
| K852665 | Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional | 08/13/1985SE |
| K851033 | Syncortech Chlamydia Direct Speciman KitLJP · Traditional | 06/21/1985SE |
| K844735 | Pth-RiaCEW · Traditional | 04/29/1985SE |
| K850726 | Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional | 03/26/1985SE |
| K850434 | CS137 Sealed SourcesKXK · Traditional | 03/26/1985SE |
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Questions and answers
When was TBG Ria cleared by the FDA?
TBG Ria (K842167) received a 510(k) decision of Substantially Equivalent on July 9, 1984, 39 days after the submission was received.
What is the product code of K842167?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.