The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Stat Campy, Model 751530.
| Device ID | K090700 |
| 510k Number | K090700 |
| Device Name: | IMMUNOCARD STAT CAMPY, MODEL 751530 |
| Classification | Campylobacter Spp. |
| 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 | LQP |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-17 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101373 | K090700 | 000 |