The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Toxoplasma Igm Clin-elisa(tm) Cat # 5560.
| Device ID | K874594 |
| 510k Number | K874594 |
| Device Name: | TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| 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 | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-03-07 |