The following data is part of a premarket notification filed by Scientific Sales Intl., Inc. with the FDA for Spr 2 Autodiluter.
Device ID | K853380 |
510k Number | K853380 |
Device Name: | SPR 2 AUTODILUTER |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
Contact | Nicolas Schmelzer |
Correspondent | Nicolas Schmelzer SCIENTIFIC SALES INTL., INC. P.O. BOX 1538 Kalamazoo, MI 49005 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-12 |
Decision Date | 1985-09-12 |