510(k) K902698
- Device
- Affinity Prolactin Test System
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K902698
- Product code
- CFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-19
- Date received
- 1990-06-19
- Regulation
- 862.1625
- Classification name
- Radioimmunoassay, Prolactin (Lactogen)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUSSELL ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3017019647
- 3009335633
- 8010132
- 3005094123
- 3006198300
- 3009984016
- 3002800697
- 9680746
- 3017894300
- 2245285
- 3005333358
- 3003741796
- 1319436
- 3022178699
- 2432235
- 3012963943
- 3004434309
- 2250051
- 1832216
- 3002809144
- 3007118747
- 9612316
- 3009491259
- 2020726
- 1222302
- 1036362
- 2517506
- 2122870
- 8031673
- 1827821
- 3011989923
- 3008198807
- 2032682
- 3033967997
- 3002642396
- 3005984081
- 2133982
- 8020888
- 3014325803
- 9610240
- 3005529799
- 1219913
- 3007111389
- 9610126
- 2029372
- 1319681
- 8021924
- 3000308930
- 3017379203
- 3002806944
- 2032839
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CFT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Monobind | 1997-06-24 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Sealite Sciences, Inc. | 1997-02-20 |
| K964748 | ELECSYS PROLACTIN ASSAY | Boehringer Mannheim Corp. | 1997-01-21 |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | 1996-04-26 |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | 1996-02-29 |
| K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-10-20 |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-10-03 |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-09-25 |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | 1995-03-21 |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | 1994-11-02 |
| K935675 | AXSYM PROLACTIN | Abbott Laboratories | 1994-06-21 |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | Dupont Medical Products | 1994-06-03 |
| K941175 | ACCESS PROLACTIN | Bio-Rad Laboratories, Inc. | 1994-06-02 |
| K930305 | COBAS CORE PROLACTIN EIA | Roche Diagnostic Systems, Inc. | 1993-08-19 |