The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Precision Culture C.a.t.s. Collect/trans Hsv I/ii.
Device ID | K872507 |
510k Number | K872507 |
Device Name: | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II |
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 | 1987-06-24 |
Decision Date | 1987-07-09 |