AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
FDA 510(k) clearance K944698 · decided 1995-03-21
Clearance details
- K-number
- K944698
- Device name
- AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-23
- Decision date
- 1995-03-21
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- CFT
- Device class
- 1
- Regulation number
- 862.1625
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921) | Monobind | 1997-06-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 |
| SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188) | Sealite Sciences, Inc. | 1997-02-20 |
| ELECSYS PROLACTIN ASSAY (K964748) | Boehringer Mannheim Corp. | 1997-01-21 |
| DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561) | Diagnostic Systems Laboratories, Inc. | 1996-04-26 |
| DSL ACTIVE PROLACTIN IRMA (K960060) | Diagnostic Systems Laboratories, Inc. | 1996-02-29 |
| ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680) | Bio-Rad Laboratories, Inc. | 1995-10-20 |
| ABBOTT IMX PROLACTIN(MODIFICATION) (K953656) | Abbott Mfg., Inc. | 1995-10-03 |
| ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657) | Abbott Mfg., Inc. | 1995-09-25 |
| ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811) | Biomerieux Vitek, Inc. | 1994-11-02 |
| AXSYM PROLACTIN (K935675) | Abbott Laboratories | 1994-06-21 |
| DUPONT ACA PLUS PROLACTIN (PROL) METHOD (K941220) | Dupont Medical Products | 1994-06-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001) | Organon Teknika Corp. | 1990-03-21 |
| HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001) | Organon Teknika Corp. | 1990-03-21 |
| 9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001) | Organon Teknika Corp. | 1990-03-21 |
| AUTOBAC MIC TEST SYSTEM (N50524/S033) | Organon Teknika Corp. | 1990-01-22 |
| AUTOBAC MIC TEST SYSTEM (N50524/S035) | Organon Teknika Corp. | 1989-12-07 |
| AUTOBAC MIC TEST SYSTEM (N50524/S032) | Organon Teknika Corp. | 1989-06-13 |
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018) | Organon Teknika Corp. | 1989-02-06 |
| AUTOBAC MIC TEST SYSTEM (N50524/S031) | Organon Teknika Corp. | 1988-12-28 |