Anti-Thyroglobulin (TG) Microplate Elisa
FDA 510(k) K971835 · Monobind
510(k) numberK971835
Submission
- Device name
- Anti-Thyroglobulin (TG) Microplate Elisa
- Applicant
- Monobind
Costa Mesa, CA, US - Received
- May 19, 1997
- Decision date
- July 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDC – Thyroglobulin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code DDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | Quest Intl., Inc. | 01/06/2003SE |
| K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models…DDC · Traditional | Beckman Coulter, Inc. | 09/07/2001SE |
| K000363 | Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Special | Zeus Scientific, Inc. | 02/18/2000SE |
| K991610 | Zeus Scientific Inc., Tpo Igg Elisa Test System.DDC · Traditional | Zeus Scientific, Inc. | 06/25/1999SE |
| K991179 | Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Traditional | Zeus Scientific, Inc. | 06/17/1999SE |
| K953066 | Serodia AtgDDC · Traditional | Fujirebio America, Inc. | 08/14/1995SE |
| K943625 | Autostat II Anti-ThyroglobulinDDC · Traditional | Cogent Diagnotics , Ltd. | 12/22/1994SE |
| K936010 | Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional | Biomerica, Inc. | 07/18/1994SE |
| K930486 | Quanta Lite(Tm) Thyroid T ElisaDDC · Traditional | Inova Diagnostics, Inc. | 03/15/1993SE |
| K865020 | Sera-Tek Thyroglobulin Antibody TestDDC · Traditional | Miles Laboratories, Inc. | 02/02/1987SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test SystemCDZ · Traditional | 07/20/2018SE |
| K063437 | Accubind Neo-Tsh Microwell Elisa, Model 3425-300JLW · Traditional | 04/04/2008SE |
| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | 08/22/2003SE |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300CEC · Traditional | 04/05/2002SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | 02/04/1998SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | 09/02/1997SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | 07/03/1997SE |
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | 06/24/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | 06/24/1997SE |
| K971779 | Total TRIIODOTHYRONINE(T3) Microplate EiaCDP · Traditional | 06/16/1997SE |
Questions and answers
When was Anti-Thyroglobulin (TG) Microplate Elisa cleared by the FDA?
Anti-Thyroglobulin (TG) Microplate Elisa (K971835) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 45 days after the submission was received.
What is the product code of K971835?
The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.