Cotube PTH Irma
FDA 510(k) K921949 · Bio-Rad
510(k) numberK921949
Submission
- Device name
- Cotube PTH Irma
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- April 27, 1992
- Decision date
- September 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1545
- Specialty
- Clinical Chemistry
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| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/05/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 11/08/2013SE |
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics | 03/21/2013SE |
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Questions and answers
When was Cotube PTH Irma cleared by the FDA?
Cotube PTH Irma (K921949) received a 510(k) decision of Substantially Equivalent on September 2, 1992, 128 days after the submission was received.
What is the product code of K921949?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.