The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Group B Streptococcus Carrot Broth Claim.
| Device ID | K121044 |
| 510k Number | K121044 |
| Device Name: | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Michelle L Smith |
| Correspondent | Michelle L Smith MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-05-01 |
| Summary: | summary |