CFT · Radioimmunoassay, Prolactin (Lactogen)
Clinical Chemistry · 21 CFR 862.1625 · Class 1
Overview
| Product Code | CFT |
|---|---|
| Device Name | Radioimmunoassay, Prolactin (Lactogen) |
| Regulation | 21 CFR 862.1625 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 80)
Showing 20 most recent of 80 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Monobind | Jun 24, 1997 | SESE |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 25, 1997 | SESE |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Sealite Sciences, Inc. | Feb 20, 1997 | SESE |
| K964748 | ELECSYS PROLACTIN ASSAY | Boehringer Mannheim Corp. | Jan 21, 1997 | SESE |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | Apr 26, 1996 | SESE |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | Feb 29, 1996 | SESE |
| K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | Oct 20, 1995 | SESE |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | Oct 3, 1995 | SESE |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | Sep 25, 1995 | SESE |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | Mar 21, 1995 | SESE |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | Nov 2, 1994 | SESE |
| K935675 | AXSYM PROLACTIN | Abbott Laboratories | Jun 21, 1994 | SESE |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | Dupont Medical Products | Jun 3, 1994 | SESE |
| K941175 | ACCESS PROLACTIN | Bio-Rad Laboratories, Inc. | Jun 2, 1994 | SESE |
| K930305 | COBAS CORE PROLACTIN EIA | Roche Diagnostic Systems, Inc. | Aug 19, 1993 | SESE |
| K926386 | VISTA PROLACTIN ASSAY | Syva Co. | Mar 29, 1993 | SESE |
| K925846 | IMMULITE PROLACTIN | Diagnostic Products Corp. | Mar 5, 1993 | SESE |
| K922715 | IMMUCHEM PRL-MW ELISA | Icn Biomedicals, Inc. | Oct 5, 1992 | SESE |
| K922170 | AMERLITE PROLACTIN-30 ASSAY | Eastman Kodak Company | Sep 2, 1992 | SESE |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Bio Clinic Co. | Apr 8, 1992 | SESE |
Top Applicants
- Diagnostic Products Corp. — 6 clearances
- Abbott Laboratories — 5 clearances
- Hybritech, Inc. — 4 clearances
- Amersham Corp. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
