Pharmacia Diagnostics, Inc.
Portage, MI, US
Pharmacia Diagnostics, Inc. appears in FDA device records in Portage, MI. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Pharmacia Diagnostics, Inc. between 1990 and 2006. The busiest year on record is 1992, with 4. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 4 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 | MST | Substantially Equivalent | |
| K051218 | MODIFICATION TO: UNICAP SPECIFIC IGE | DHB | Substantially Equivalent | |
| K921011 | PHARMACIA CMV IGM ELISA | LFZ | Substantially Equivalent | |
| K920702 | TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO | LGD | Substantially Equivalent | |
| K915348 | EBV-VCA IGM ELISA | LJN | Substantially Equivalent | |
| K914022 | SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS | LFY | Substantially Equivalent | |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | JLX | Substantially Equivalent | |
| K902793 | RUBELLA IGG | LFX | Substantially Equivalent | |
| K902792 | TOXOPLASMA GONDII IGG | LGD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MSTAntibodies, Gliadin
- LJNAntibody Igm, If, Epstein-Barr Virus
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain