Standards, Hormone, Thyroid Stimulating
FDA 510(k) K781071 · Pcl-Ria, Inc.
510(k) numberK781071
Submission
- Device name
- Standards, Hormone, Thyroid Stimulating
- Applicant
- Pcl-Ria, Inc.
Mchenry, IL, US - Received
- June 26, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K830526 | B-Gcg System by RiaJHI · Traditional | 04/05/1983SE |
| K823014 | Digoxin KitDPB · Traditional | 11/01/1982SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | 11/01/1982SE |
| K822612 | T3 Uptake KitsKHQ · Traditional | 09/30/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | 04/16/1982SE |
| K820358 | Follicle Stimulating Hormone KitCGJ · Traditional | 03/26/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | 03/25/1982SE |
| K812666 | Thyroxine (T4) 125ICDP · Traditional | 10/02/1981SE |
| K810867 | Follicle Stimulating Hormone (FSH)JIS · Traditional | 04/14/1981SE |
| K810852 | Follicle Stimulating Hormone AntiserumCGJ · Traditional | 04/08/1981SE |
Questions and answers
When was Standards, Hormone, Thyroid Stimulating cleared by the FDA?
Standards, Hormone, Thyroid Stimulating (K781071) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 49 days after the submission was received.
What is the product code of K781071?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.