Sealite Sciences, Inc. Aqualite Human Growth Hormone Assay
FDA 510(k) K972761 · Sealite Sciences, Inc.
510(k) numberK972761
Submission
- Device name
- Sealite Sciences, Inc. Aqualite Human Growth Hormone Assay
- Applicant
- Sealite Sciences, Inc.
Norcross, GA, US - Received
- July 24, 1997
- Decision date
- September 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFL – Radioimmunoassay, Human Growth Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1370
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971353 | DSL Active Non-Extraction Igf-I ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 05/12/1997SE |
| K970701 | DSL 1900 Active Human Growth Hormone Irma (DSL 1900)CFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/02/1997SE |
| K962758 | DSL 9100 Igf-Ii IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 08/30/1996SE |
| K961678 | Human Growth Hormone Immunoassay KitCFL · Traditional | Nichols Institute Diagnostics | 07/08/1996SE |
| K961172 | DSL Active Non-Extraction Igf-I IrmaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 04/23/1996SE |
| K960551 | DSL Active Human Growth Hormone ElisaCFL · Traditional | Diagnostic Systems Laboratories, Inc. | 03/06/1996SE |
| K955376 | Immulite HGHCFL · Traditional | Diagnostic Products Corp. | 02/16/1996SE |
| K955390 | Insulin-Like Growth Factor-I (Igf-I) Immunoradiometric AssayCFL · Traditional | Corning Nichols Diagnostics | 12/29/1995SE |
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma)CFL · Traditional | Nichols Institute | 07/03/1995SE |
| K946247 | IGFBP-3; Insulin-Like Growth Factor Binding PROTEIN-3CFL · Traditional | Nichols Institute | 06/23/1995SE |
More from Nichols Institute
| 510(k) | Device | Decision |
|---|---|---|
| K974551 | Sealite Sciences, Inc. Aqualite Free T, AssayCEC · Traditional | 12/22/1997SE |
| K970612 | Sealite Sciences, Inc. Aqualite Ferritin AssayDBF · Traditional | 06/24/1997SE |
| 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 Human Growth Hormone Assay cleared by the FDA?
Sealite Sciences, Inc. Aqualite Human Growth Hormone Assay (K972761) received a 510(k) decision of Substantially Equivalent on September 25, 1997, 63 days after the submission was received.
What is the product code of K972761?
The FDA product code is CFL – Radioimmunoassay, Human Growth Hormone, a Class I (low risk) device regulated under 21 CFR 862.1370.