The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Elisa Cmv Igm.
Device ID | K914789 |
510k Number | K914789 |
Device Name: | ELISA CMV IGM |
Classification | Antibody Igm,if, Cytomegalovirus Virus |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | Martin King |
Correspondent | Martin King SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | LKQ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-23 |
Decision Date | 1992-03-04 |