Thyroglobulin Autoantibody Enzyme Immunoassay
FDA 510(k) K936010 · Biomerica, Inc.
510(k) numberK936010
Submission
- Device name
- Thyroglobulin Autoantibody Enzyme Immunoassay
- Applicant
- Biomerica, Inc.
Newport Beach, CA, US - Received
- December 16, 1993
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | Monobind | 07/03/1997SE |
| K953066 | Serodia AtgDDC · Traditional | Fujirebio America, Inc. | 08/14/1995SE |
| K943625 | Autostat II Anti-ThyroglobulinDDC · Traditional | Cogent Diagnotics , Ltd. | 12/22/1994SE |
| 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 |
|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISALYR · Traditional | 12/15/2023SE |
| K003856 | Ez-Hcg Urine(Pregnancy Test)JHI · Traditional | 02/21/2001SE |
| K982954 | Free T4 Microwell Eia, Model #7019CEC · Traditional | 09/24/1998SE |
| K962216 | TSH (Microwell) ElisaJLW · Traditional | 09/19/1996SE |
| K960412 | T-3 Microwell Eia Model 7013CDP · Traditional | 03/19/1996SE |
| K954256 | Anti-TpoJNL · Traditional | 11/27/1995SE |
| K950588 | T4 Microwell Eia (Enzyme IMMUNOASSAY0KLI · Traditional | 06/29/1995SE |
| K915185 | Gap Igg H.Pylori ModifiedLYR · Traditional | 03/04/1992SE |
| K900343 | Gap-IggLYR · Traditional | 08/22/1991SE |
Questions and answers
When was Thyroglobulin Autoantibody Enzyme Immunoassay cleared by the FDA?
Thyroglobulin Autoantibody Enzyme Immunoassay (K936010) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 214 days after the submission was received.
What is the product code of K936010?
The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.