510(k) K082562
- Device
- APPLIED BIOSYSTEMS 7500 FAST DX
- Applicant
- APPLIED BIOSYSTEMS INC
- 510(k) number
- K082562
- Product code
- NSU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-30
- Date received
- 2008-09-04
- Regulation
- 862.2570
- Classification name
- Instrumentation For Clinical Multiplex Test Systems
- Medical specialty
- Clinical Chemistry
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D'ANGELO
- Address
- 850 Lincoln Center Dr. Foster City CA US 94404 94404
FDA Registration Numbers#
- 3032023483
- 3005370583
- 3003673482
- 3007799234
- 3007886270
- 1650733
- 3003540236
- 3004105270
- 3006198300
- 3004141078
- 3016611336
- 3021389305
- 2243471
- 3008632402
- 2024800
- 3010770794
- 3007361513
- 3007208259
- 9615056
- 8020030
- 2032682
- 3004530258
- 3003366417
- 3017358793
- 3007719797
- 3016838963
- 9610126
- 3003795116
- 3008494306
- 3002773840
- 1628664
- 3010286073
- 3003423869
- 3017907743
- 3017019647
- 3012348571
- 3012259842
- 3003314809
- 3035381641
- 3014214006
- 3009189893
- 3007143373
- 3016733849
- 3005406097
- 3016531205
- 3013019728
- 3006028115
- 3013540184
- 3042641161
- 2915274
- 1119779
- 2026994
- 3014325803
- 3014515702
- 3005269352
- 3007420875
- 3005967741
- 3002777243
- 3016068451
- 3038610665
- 8043379
- 2183715
- 3007118747
Source Documents#
Other 510(k) Records For Product Code NSU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163652 | ePlex Instrument | Genmark Diagnostics, Incorporated | 2017-06-09 |
| K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | 2015-01-30 |
| K133849 | VANTERA CLINICAL ANALYZER | Liposcience | 2014-10-22 |
| K141220 | APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE | Thermo Fisher Scientific (Life Technologies Holdin | 2014-05-22 |
| K133302 | FLEXMAP 3D | Luminex Corp. | 2014-01-10 |
| K121399 | LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P | Luminex Corp. | 2013-01-09 |
| K110786 | ESENSOR WARFARIN SENSITIVITY SALIVA TEST | GenMark Diagnostics, Inc. | 2011-12-02 |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | Illumina, Inc. | 2010-04-28 |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | 2008-07-30 |
| K073506 | LUMINEX LX 100/200 INSTRUMENT | Luminex Corp. | 2008-03-07 |
| K070597 | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST | Nanosphere, Inc. | 2007-10-11 |
| DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | Affymetrix, Inc. | 2004-12-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary