The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Coccidioides Immitis, Antigen.
| Device ID | K792682 |
| 510k Number | K792682 |
| Device Name: | COCCIDIOIDES IMMITIS, ANTIGEN |
| Classification | Antigen, Cf And / Or Id, Coccidioides Immitis |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMI |
| CFR Regulation Number | 866.3135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-27 |
| Decision Date | 1980-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101076 | K792682 | 000 |
| 00840733101045 | K792682 | 000 |
| 00840733101038 | K792682 | 000 |