Sealite Sciences, Inc. Aqualite Prolactin
FDA 510(k) K970188 · Sealite Sciences, Inc.
510(k) numberK970188
Submission
- Device name
- Sealite Sciences, Inc. Aqualite Prolactin
- Applicant
- Sealite Sciences, Inc.
Norcross, GA, US - Received
- January 17, 1997
- Decision date
- February 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFT – Radioimmunoassay, Prolactin (Lactogen)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1625
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | Monobind | 06/24/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/25/1997SE |
| K964748 | Elecsys Prolactin AssayCFT · Traditional | Boehringer Mannheim Corp. | 01/21/1997SE |
| K960561 | DSL Active Prolactin Elisa Model 10-4500CFT · Traditional | Diagnostic Systems Laboratories, Inc. | 04/26/1996SE |
| K960060 | DSL Active Prolactin IrmaCFT · Traditional | Diagnostic Systems Laboratories, Inc. | 02/29/1996SE |
| K954680 | Access Prolactin Assay (Modification)CFT · Traditional | Bio-Rad Laboratories, Inc. | 10/20/1995SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 09/25/1995SE |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional | Organon Teknika Corp. | 03/21/1995SE |
| K943811 | Enzyme-Linked Fluorescent ImmunoassayCFT · Traditional | Biomerieux Vitek, Inc. | 11/02/1994SE |
More from Biomerieux Vitek, 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 |
| K970612 | Sealite Sciences, Inc. Aqualite Ferritin AssayDBF · Traditional | 06/24/1997SE |
| K970483 | Aqualite Intact PTHCEW · Traditional | 04/14/1997SE |
| 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 Prolactin cleared by the FDA?
Sealite Sciences, Inc. Aqualite Prolactin (K970188) received a 510(k) decision of Substantially Equivalent on February 20, 1997, 34 days after the submission was received.
What is the product code of K970188?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.