The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Igm Cmv Clin-elisa(tm) Test System Number: 5530.
Device ID | K872942 |
510k Number | K872942 |
Device Name: | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 |
Classification | Antibody Igm,if, Cytomegalovirus Virus |
Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
Contact | Marylou Panico |
Correspondent | Marylou Panico CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
Product Code | LKQ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-27 |
Decision Date | 1988-01-11 |