The following data is part of a premarket notification filed by Corning Costar Corp. with the FDA for Serocluster Flexible Vinyl U & V Pl..
Device ID | K803243 |
510k Number | K803243 |
Device Name: | SEROCLUSTER FLEXIBLE VINYL U & V PL. |
Classification | Device, Microtiter Diluting/dispensing |
Applicant | CORNING COSTAR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-23 |
Decision Date | 1981-01-28 |