510(k) K090191
- Device
- HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
- Applicant
- HANDYLAB, INC
- 510(k) number
- K090191
- Product code
- NJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-27
- Date received
- 2009-01-27
- Regulation
- 866.3740
- Classification name
- Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTHA J RUMFORD
- Address
- 5230 S. State Rd. Ann Arbor MI US 48108 48108
FDA Registration Numbers#
- 2024800
- 1119779
- 2023365
- 3007420875
- 3026312356
- 3004530258
- 3012918440
- 1524213
- 3016838963
- 3016733849
- 3009613136
- 3006198300
- 1528450
Source Documents#
Other 510(k) Records For Product Code NJR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid | 2023-09-27 |
| K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | 2022-05-09 |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | Diasorin Molecular, LLC | 2018-11-07 |
| K181156 | Panther Fusion GBS Assay | Diagenode | 2018-07-27 |
| K173725 | NeuMoDx GBS Assay | Neumodx Molecular, Inc. | 2018-06-26 |
| K173250 | Solana GBS Assay | Quidel Corporation | 2017-12-21 |
| K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017-05-25 |
| K162772 | ARIES GBS Assay | Luminex Corporation | 2016-12-23 |
| K143312 | Portrait GBS Assay | Great Basin Corporation | 2015-04-21 |
| K133503 | AMPLIVUE GBS ASSAY | Quidel Corporation | 2013-12-20 |
| K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) | Cepheid | 2012-11-02 |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | Meridian Bioscience, Inc. | 2012-05-01 |
| K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT | Becton, Dickinson & CO | 2012-02-16 |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | Meridian Bioscience, Inc. | 2011-12-05 |
| K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B | Cepheid | 2006-12-08 |
Legacy Summary#
summary
FDA Review#
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