Aqualite Intact PTH
FDA 510(k) K970483 · Sealite Sciences, Inc.
510(k) numberK970483
Submission
- Device name
- Aqualite Intact PTH
- Applicant
- Sealite Sciences, Inc.
Norcross, GA, US - Received
- February 10, 1997
- Decision date
- April 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code CEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STATCEW · Traditional | Roche Diagnostics | 03/22/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | Ortho Clinical Diagnostics | 09/05/2023SE |
| K190702 | Lumipulse G whole PTHCEW · Traditional | Fujirebio Diagnostics,Inc. | 08/30/2019SE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2017SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | Immunodiagnostic Systems , Ltd. | 01/31/2017SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 06/22/2015SE |
| 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 |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K974551 | Sealite Sciences, Inc. Aqualite Free T, AssayCEC · Traditional | 12/22/1997SE |
| K972761 | Sealite Sciences, Inc. Aqualite Human Growth Hormone AssayCFL · Traditional | 09/25/1997SE |
| K970612 | Sealite Sciences, Inc. Aqualite Ferritin AssayDBF · Traditional | 06/24/1997SE |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | 02/20/1997SE |
| K970085 | Sealite Sciences Aqualite FSHCGJ · Traditional | 02/14/1997SE |
| K964925 | Sealite Sciences, Inc. Aqualite LHCEP · Traditional | 01/22/1997SE |
| K942661 | Aqualite TSH Bioluminescent Immunoassay KitJLW · Traditional | 01/17/1995SE |
| K943437 | Aqualite FSHCGJ · Traditional | 12/28/1994SE |
| K943188 | Sealite Science, Inc. Aqualite(R) LHCEP · Traditional | 10/20/1994SE |
| K941983 | Sealite Sciences Inc.DHA · Traditional | 08/18/1994SE |
Questions and answers
When was Aqualite Intact PTH cleared by the FDA?
Aqualite Intact PTH (K970483) received a 510(k) decision of Substantially Equivalent on April 14, 1997, 63 days after the submission was received.
What is the product code of K970483?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.