Sealite Sciences, Inc. Aqualite Ferritin Assay
FDA 510(k) K970612 · Sealite Sciences, Inc.
510(k) numberK970612
Submission
- Device name
- Sealite Sciences, Inc. Aqualite Ferritin Assay
- Applicant
- Sealite Sciences, Inc.
Norcross, GA, US - Received
- February 18, 1997
- Decision date
- June 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | Kamiya Biomedical Company | 05/24/2012SE |
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| K092505 | Beckman Coulter Ferritin Reagent, Model: OSR61203DBF · Traditional | Beckman Coulter, Inc. | 12/11/2009SE |
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| K053211 | Rdi Hsferritin KitDBF · Traditional | Reference Diagnostics, Inc. | 03/13/2006SE |
More from Reference Diagnostics, Inc.
| 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 |
| K970483 | Aqualite Intact PTHCEW · Traditional | 04/14/1997SE |
| 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 Sealite Sciences, Inc. Aqualite Ferritin Assay cleared by the FDA?
Sealite Sciences, Inc. Aqualite Ferritin Assay (K970612) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 126 days after the submission was received.
What is the product code of K970612?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.