HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
FDA 510(k) clearance K090191 · decided 2010-05-27
Clearance details
- K-number
- K090191
- Device name
- HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB
- Applicant
- Handylab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-27
- Decision date
- 2010-05-27
- Days to decision
- 485 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638) | Cepheid | 2023-09-27 |
| Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429) | Cepheid | 2022-05-09 |
| Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467) | Diasorin Molecular, LLC | 2018-11-07 |
| Panther Fusion GBS Assay (K181156) | Diagenode | 2018-07-27 |
| NeuMoDx GBS Assay (K173725) | Neumodx Molecular, Inc. | 2018-06-26 |
| Solana GBS Assay (K173250) | Quidel Corporation | 2017-12-21 |
| GenePOC GBS LB (K170557) | Genepoc, Inc. | 2017-05-25 |
| ARIES GBS Assay (K162772) | Luminex Corporation | 2016-12-23 |
| Portrait GBS Assay (K143312) | Great Basin Corporation | 2015-04-21 |
| AMPLIVUE GBS ASSAY (K133503) | Quidel Corporation | 2013-12-20 |
| XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) | Cepheid | 2012-11-02 |
| ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044) | Meridian Bioscience, Inc. | 2012-05-01 |
Recalls involving this device
No recalls on record reference this clearance.