The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Pharmacia Cmv Igm Elisa.
| Device ID | K921011 |
| 510k Number | K921011 |
| Device Name: | PHARMACIA CMV IGM ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 |
| Contact | Steven Vinson |
| Correspondent | Steven Vinson PHARMACIA DIAGNOSTICS, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746991 | K921011 | 000 |
| 05391516743426 | K921011 | 000 |
| 05391516743419 | K921011 | 000 |