Sera-Tek Thyroglobulin Antibody Test
FDA 510(k) K865020 · Miles Laboratories, Inc.
510(k) numberK865020
Submission
- Device name
- Sera-Tek Thyroglobulin Antibody Test
- Applicant
- Miles Laboratories, Inc.
Elkhart, IN, US - Received
- December 23, 1986
- Decision date
- February 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K930486 | Quanta Lite(Tm) Thyroid T ElisaDDC · Traditional | Inova Diagnostics, Inc. | 03/15/1993SE |
More from Inova Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Sera-Tek Thyroglobulin Antibody Test cleared by the FDA?
Sera-Tek Thyroglobulin Antibody Test (K865020) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 41 days after the submission was received.
What is the product code of K865020?
The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.