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)

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K871972 · 1987-07-21

ApplicantAmerican Dade
Decision Date1987-07-21
Product CodeDGE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K871972. The device is classified under product code DGE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is American Dade. The 510(k) number is K871972.

When did STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-07-21, under 510(k) number K871972.

Who is the listed applicant for STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY is DGE.

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 American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

View all 149 devices →

Related Devices (Code: DGE)

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.

K915838OPUS FERRITIN TEST SYSTEMPb Diagnostic Systems, Inc.

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.

↑