Zeus Scientific Inc., Tpo Igg Elisa Test System.
FDA 510(k) K991610 · Zeus Scientific, Inc.
510(k) numberK991610
Submission
- Device name
- Zeus Scientific Inc., Tpo Igg Elisa Test System.
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- May 10, 1999
- Decision date
- June 25, 1999
- 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
| 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 |
| 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 |
| 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 |
|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | 08/21/2026SE |
| K250814 | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional | 05/08/2026SE |
| K250666 | Alegria Flash CTD ScreenLLL · Traditional | 10/22/2025SE |
| K250408 | Alegria Flash ENA ScreenLLL · Traditional | 09/19/2025SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | 05/07/2025SE |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional | 08/31/2023SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | 07/13/2023SE |
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFineDHN · Traditional | 04/29/2022SE |
| K191398 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
| K191240 | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi…LSR · Traditional | 07/29/2019SE |
Questions and answers
When was Zeus Scientific Inc., Tpo Igg Elisa Test System. cleared by the FDA?
Zeus Scientific Inc., Tpo Igg Elisa Test System. (K991610) received a 510(k) decision of Substantially Equivalent on June 25, 1999, 46 days after the submission was received.
What is the product code of K991610?
The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.