The following data is part of a premarket notification filed by Handylab, Inc with the FDA for Handylab Gbs Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab E3 Extraction Reagent, Handylab.
| Device ID | K090191 |
| 510k Number | K090191 |
| Device Name: | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | HANDYLAB, INC 5230 S STATE ROAD Ann Arbor, MI 48108 |
| Contact | Martha J Rumford |
| Correspondent | Martha J Rumford HANDYLAB, INC 5230 S STATE ROAD Ann Arbor, MI 48108 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2010-05-27 |
| Summary: | summary |