The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Toxoplasma Gondii (toxo) Igm Enzyme-linked Immuno.
| Device ID | K920702 |
| 510k Number | K920702 |
| Device Name: | TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 350 PASSAIC AVE. Fairfield, NJ 07004 |
| Contact | Steven Vinson |
| Correspondent | Steven Vinson PHARMACIA DIAGNOSTICS, INC. 350 PASSAIC AVE. Fairfield, NJ 07004 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746977 | K920702 | 000 |
| 05391516743396 | K920702 | 000 |
| 05391516743389 | K920702 | 000 |
| 05391516747479 | K920702 | 000 |
| 05391516746823 | K920702 | 000 |