Technicon Ra(R) Analyte (TBG) (30 C and 37 C)
FDA 510(k) K874658 · Technicon Instruments Corp.
510(k) numberK874658
Submission
- Device name
- Technicon Ra(R) Analyte (TBG) (30 C and 37 C)
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- November 12, 1987
- Decision date
- December 18, 1987
- 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
Other 510(k)s with product code CEE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K862109 | Enzymun Test TBGCEE · Traditional | Boehringer Mannheim Corp. | 06/30/1986SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon Ra(R) Analyte (TBG) (30 C and 37 C) cleared by the FDA?
Technicon Ra(R) Analyte (TBG) (30 C and 37 C) (K874658) received a 510(k) decision of Substantially Equivalent on December 18, 1987, 36 days after the submission was received.
What is the product code of K874658?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.