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Medical device manufacturer

Pharmacia, Inc.

Pharmacia, Inc. holds 129 FDA 510(k) clearances across 46 product codes. Median elapsed review time is 56 days. openFDA lists no recall records naming the company.

Updated · ingest status · JSON

510(k) clearances
129
Product codes
46
Median review
56 days
Recall records
0

How does FDA spell Pharmacia, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Pharmacia, Inc. file in?

46 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
DHBSystem, Test, Radioallergosorbent (Rast) Immunological3953 days
DGCIge, Antigen, Antiserum, Control1636 days
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use534 days
JZGSystem, Test, Beta-2-Microglobulin Immunological558 days
GTZAntisera, All Groups, Streptococcus Spp.435 days
FMFSyringe, Piston357 days
HDRCap, Cervical381 days
JQWStation, Pipetting And Diluting, For Clinical Use386 days
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular3121 days
CHPRadioimmunoassay, Estradiol220 days
GTJAntisera, All Groups, N. Meningitidis2101 days
GTYAntigens, All Groups, Streptococcus Spp.252 days
JHRRadioimmunoassay, Immunoglobulins (D, E)241 days
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)232 days
JLWRadioimmunoassay, Thyroid-Stimulating Hormone262 days
LICAntiserum, Coagglutination (Direct) Neisseria Gonorrhoeae244 days
LLDPort & Catheter, Implanted, Subcutaneous, Intraperitoneal2132 days
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)112 days
CDPRadioimmunoassay, Total Triiodothyronine185 days
CDXRadioimmunoassay, Total Thyroxine1117 days
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone1111 days
CECRadioimmunoassay, Free Thyroxine160 days
CEERadioimmunoassay, Thyroxine-Binding Globulin172 days
CEPRadioimmunoassay, Luteinizing Hormone1181 days
CFPRadioimmunoassay, Immunoreactive Insulin125 days

Showing the 25 they file in most, of 46.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Pharmacia, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Pharmacia, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K974350ALLERGAN IMMUNO CAP M4, M8, K70DHB82
K972364UNICAP PHADIATOPDHB71
K972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82DHB30
K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0JQW147
K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHDGC189
K962274UNICAP 100DHB91
K941993PHARMACIA CAP SYSTEM PHADIATOP FEIADHB645
K954337GENOTROPIN MIXERFMF56
K951025PISTON SYRINGEFMF227
K952025ROBOCAPJQW86

Source: openFDA device/510k · retrieved

Watch what Pharmacia, Inc. files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.