Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.
FDA 510(k) K895648 · Ventrex Laboratories, Inc.
510(k) numberK895648
Submission
- Device name
- Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- September 20, 1989
- Decision date
- January 18, 1990
- 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
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| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
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| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
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| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
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| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan. cleared by the FDA?
Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan. (K895648) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 120 days after the submission was received.
What is the product code of K895648?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.