The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Cary-blair Transport System.
Device ID | K885245 |
510k Number | K885245 |
Device Name: | CARY-BLAIR TRANSPORT SYSTEM |
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 |