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 |