The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Cat. #9972 Refrigeration Medium (test Yolk Buffer).
| Device ID | K872203 |
| 510k Number | K872203 |
| Device Name: | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) |
| Classification | Cap, Cervical |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Paul S Weathersbee |
| Correspondent | Paul S Weathersbee IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-08-14 |