Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pharmacia & Upjohn Co. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
94 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003414 | VARELISA TG (THYROGLOBULIN) ANTIBODIES, | Pharmacia & Upjohn Co. | 2000-11-27 | 25 | 0 |
| K002556 | CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 | Pharmacia & Upjohn Co. | 2000-10-31 | 75 | 0 |
| K000312 | VARELISA SM ANTIBODIES | Pharmacia & Upjohn Co. | 2000-03-17 | 45 | 0 |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, | Pharmacia & Upjohn Co. | 2000-02-18 | 31 | 0 |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | Pharmacia & Upjohn Co. | 2000-01-05 | 75 | 0 |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F | Pharmacia & Upjohn Co. | 1999-12-01 | 54 | 0 |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | 1999-11-26 | 35 | 0 |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999-11-12 | 56 | 0 |
| K993109 | VARELISA RECOMBI ANA PROFILE | Pharmacia & Upjohn Co. | 1999-11-12 | 56 | 0 |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | 1999-07-28 | 49 | 0 |
| K991048 | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F2 | Pharmacia & Upjohn Co. | 1999-05-14 | 45 | 0 |
| K982533 | UNICAP GLIADIN IGA ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | 94 | 0 |
| K982701 | UNICAP GLIADIN IGG ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | 94 | 0 |
| K982343 | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, | Pharmacia & Upjohn Co. | 1998-09-15 | 71 | 0 |
| K981930 | UNICAP THYROID PEROXIDASE IGG | Pharmacia & Upjohn Co. | 1998-07-07 | 67 | 0 |
| K981559 | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IG | Pharmacia & Upjohn Co. | 1998-07-07 | 67 | 0 |
| K974580 | ALLERGEN IMMUNOCAP F256,F245,F207,F202 | Pharmacia & Upjohn Co. | 1998-02-09 | 63 | 0 |
| K962976 | PHARMACIA CAP SYSTEM RAST FEIA | Pharmacia & Upjohn Co. | 1996-12-23 | 145 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda