The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Pdc 104 & Pdc 304 Style Culture Collection & Trans.
Device ID | K844634 |
510k Number | K844634 |
Device Name: | PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS |
Classification | Culture Media, Non-propagating Transport |
Applicant | PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
Contact | Gino Franco |
Correspondent | Gino Franco PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-27 |
Decision Date | 1985-01-30 |