Quanta Lite(Tm) Thyroid T Elisa
FDA 510(k) K930486 · Inova Diagnostics, Inc.
510(k) numberK930486
Submission
- Device name
- Quanta Lite(Tm) Thyroid T Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- January 29, 1993
- Decision date
- March 15, 1993
- 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 |
| 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 |
| K865020 | Sera-Tek Thyroglobulin Antibody TestDDC · Traditional | Miles Laboratories, Inc. | 02/02/1987SE |
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| K213403 | Aptiva CTD Essential ReagentLLL · Traditional | 09/29/2023SE |
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | 06/16/2021SE |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional | 12/11/2020SE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | 10/16/2018SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
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Questions and answers
When was Quanta Lite(Tm) Thyroid T Elisa cleared by the FDA?
Quanta Lite(Tm) Thyroid T Elisa (K930486) received a 510(k) decision of Substantially Equivalent on March 15, 1993, 45 days after the submission was received.
What is the product code of K930486?
The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.