The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Histoplasma Capsulatum, Antiserum.
| Device ID | K792679 |
| 510k Number | K792679 |
| Device Name: | HISTOPLASMA CAPSULATUM, ANTISERUM |
| Classification | Antiserum, Positive Control, Histoplasma Capsulatum |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GMK |
| CFR Regulation Number | 866.3320 [🔎] |
| 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 |
|---|---|---|
| 00840733101052 | K792679 | 000 |