125 I-T3 Uptake Reagent
FDA 510(k) K780671 · Radioimmunoassay, Inc.
510(k) numberK780671
Submission
- Device name
- 125 I-T3 Uptake Reagent
- Applicant
- Radioimmunoassay, Inc.
Mchenry, IL, US - Received
- April 24, 1978
- Decision date
- June 6, 1978
- 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 |
|---|---|---|
| K802135 | Testosterone Radioimmunoassy KitCDZ · Traditional | 10/10/1980SE |
| K800107 | Follicle Stimulating HormoneCGJ · Traditional | 02/13/1980SE |
| K800106 | Luteinizing Hormone Radioimmunoassay SysCEP · Traditional | 02/13/1980SE |
| K792539 | Triiodothyronine Ria SystemCDP · Traditional | 01/16/1980SE |
| K792154 | Thyroid Stimulating HormoneJLW · Traditional | 11/13/1979SE |
| K792153 | Digoxin Radioimmunoassay SystemDPB · Traditional | 11/13/1979SE |
| K792036 | Cortisol Radioimmunoassay SystemCGR · Traditional | 10/30/1979SE |
| K780672 | 125 I-T4 Ria ReagentCDX · Traditional | 06/06/1978SE |
Questions and answers
When was 125 I-T3 Uptake Reagent cleared by the FDA?
125 I-T3 Uptake Reagent (K780671) received a 510(k) decision of Substantially Equivalent on June 6, 1978, 43 days after the submission was received.
What is the product code of K780671?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.