The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Agar Reduction In Formula For Pdc 110 & 310 Media.
| Device ID | K863164 |
| 510k Number | K863164 |
| Device Name: | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Contact | Gino Franco |
| Correspondent | Gino Franco PRECISION DYNAMICS CORP. 13880 DEL SUR ST. San Fernando, CA 91340 -3490 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-18 |
| Decision Date | 1986-08-27 |