The following data is part of a premarket notification filed by In Vitro Scientific Products with the FDA for In Vitro 2.5x Roller Bottle.
Device ID | K873137 |
510k Number | K873137 |
Device Name: | IN VITRO 2.5X ROLLER BOTTLE |
Classification | Bottle, Roller, Tissue Culture |
Applicant | IN VITRO SCIENTIFIC PRODUCTS 2350 VALLEY MEADOW DR. Oak View, CA 93022 |
Contact | Jonathan M Serkes |
Correspondent | Jonathan M Serkes IN VITRO SCIENTIFIC PRODUCTS 2350 VALLEY MEADOW DR. Oak View, CA 93022 |
Product Code | KJC |
CFR Regulation Number | 864.2240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-08-24 |