Sealite Sciences, Inc. Aqualite Free T, Assay
FDA 510(k) K974551 · Sealite Sciences, Inc.
510(k) numberK974551
Submission
- Device name
- Sealite Sciences, Inc. Aqualite Free T, Assay
- Applicant
- Sealite Sciences, Inc.
Norcross, GA, US - Received
- December 4, 1997
- Decision date
- December 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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| 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 |
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Questions and answers
When was Sealite Sciences, Inc. Aqualite Free T, Assay cleared by the FDA?
Sealite Sciences, Inc. Aqualite Free T, Assay (K974551) received a 510(k) decision of Substantially Equivalent on December 22, 1997, 18 days after the submission was received.
What is the product code of K974551?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.