Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHARMACIA IGE EIA

K-Number: K873077 · 1987-10-20

ApplicantPharmacia, Inc.
Decision Date1987-10-20
Product CodeJHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHARMACIA IGE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873077. The device is classified under product code JHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACIA IGE EIA?

PHARMACIA IGE EIA is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Pharmacia, Inc.. The 510(k) number is K873077.

When did PHARMACIA IGE EIA receive FDA 510(k) clearance?

PHARMACIA IGE EIA received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873077.

Who is the listed applicant for PHARMACIA IGE EIA?

The FDA 510(k) record lists Pharmacia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMACIA IGE EIA?

The FDA product code for PHARMACIA IGE EIA is JHR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pharmacia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

View all 129 devices →

Related Devices (Code: JHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061970ELECSYS IGE II IMMUNOASSAYRoche DiagnosticsK984326ELECYS IGE ASSAYBoehringer Mannheim Corp.K960067IMMILITE TOTAL IGEDiagnostic Products Corp.K931703IMMULITE TOTAL IGEDiagnostic Products Corp.K903000TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.K901859COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2Diagnostic Products Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑