The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Coccidioides.
| Device ID | K915493 |
| 510k Number | K915493 |
| Device Name: | PREMIER COCCIDIOIDES |
| Classification | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen Nickol |
| Correspondent | Allen Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | MIY |
| CFR Regulation Number | 866.3135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101236 | K915493 | 000 |