The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Saf Fecal Collection Kit.
| Device ID | K885244 |
| 510k Number | K885244 |
| Device Name: | SAF FECAL COLLECTION KIT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Contact | Tony Bebbington |
| Correspondent | Tony Bebbington PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-22 |
| Decision Date | 1989-03-21 |