Amerlite TBG Assay, LAN.0005/1005 240/144 Test Kit
FDA 510(k) K893469 · Amersham Corp.
510(k) numberK893469
Submission
- Device name
- Amerlite TBG Assay, LAN.0005/1005 240/144 Test Kit
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- May 4, 1989
- Decision date
- August 15, 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
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 |
| 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 |
| K862109 | Enzymun Test TBGCEE · Traditional | Boehringer Mannheim Corp. | 06/30/1986SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Amerlite TBG Assay, LAN.0005/1005 240/144 Test Kit cleared by the FDA?
Amerlite TBG Assay, LAN.0005/1005 240/144 Test Kit (K893469) received a 510(k) decision of Substantially Equivalent on August 15, 1989, 103 days after the submission was received.
What is the product code of K893469?
The FDA product code is CEE – Radioimmunoassay, Thyroxine-Binding Globulin, a Class II (moderate risk) device regulated under 21 CFR 862.1685.