Elisa Tube Prolactin Test Kit
FDA 510(k) K920921 · Bio Clinic Co.
510(k) numberK920921
Submission
- Device name
- Elisa Tube Prolactin Test Kit
- Applicant
- Bio Clinic Co.
St. Louis, MI, US - Received
- February 28, 1992
- Decision date
- April 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
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|---|---|---|
| K930791 | American Power Conversions, Back-Ups 600FMF · Traditional | 08/06/1993SE |
| K932480 | PrismIOQ · Traditional | 07/21/1993SE |
| K926189 | Orthoderm Consummate Air Therapy Bed W/ScaleIOQ · Traditional | 06/24/1993SE |
| K921958 | Elisa Tube TSH TestJLW · Traditional | 07/02/1992SE |
| K922140 | Orthoderm Convertible IIIOQ · Traditional | 05/27/1992SE |
| K921212 | Mirco Elisa HPL Test KitJHI · Traditional | 05/07/1992SE |
| K921211 | Now Pregnancy Test KitJHI · Traditional | 05/07/1992SE |
| K920920 | Elisa Tube LH Test KitCEP · Traditional | 04/08/1992SE |
| K920918 | TMB Chromogen/Substrate Reagent SetJHI · Traditional | 04/07/1992SE |
| K920917 | Elisa Tube FSH Test Kit Enzyme Linked Immun. AssayCGJ · Traditional | 03/26/1992SE |
Questions and answers
When was Elisa Tube Prolactin Test Kit cleared by the FDA?
Elisa Tube Prolactin Test Kit (K920921) received a 510(k) decision of Substantially Equivalent on April 8, 1992, 40 days after the submission was received.
What is the product code of K920921?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.