Tandem - Eprl
FDA 510(k) K843804 · Hybritech, Inc.
510(k) numberK843804
Submission
- Device name
- Tandem - Eprl
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- September 27, 1984
- Decision date
- November 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | Sealite Sciences, Inc. | 02/20/1997SE |
| 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 |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 08/19/1996SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
Questions and answers
When was Tandem - Eprl cleared by the FDA?
Tandem - Eprl (K843804) received a 510(k) decision of Substantially Equivalent on November 13, 1984, 47 days after the submission was received.
What is the product code of K843804?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.