The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Respiracult-strep Deep Bed Culture Pad.
| Device ID | K821659 |
| 510k Number | K821659 |
| Device Name: | RESPIRACULT-STREP DEEP BED CULTURE PAD |
| Classification | Culture Media, Non-selective And Differential |
| Applicant | ORION DIAGNOSTICA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSH |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-04 |
| Decision Date | 1982-08-05 |