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)

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT

K-Number: K800398 · 1980-03-12

ApplicantDiagnostica, Inc.
Decision Date1980-03-12
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800398. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT?

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Diagnostica, Inc.. The 510(k) number is K800398.

When did PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT receive FDA 510(k) clearance?

PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800398.

Who is the listed applicant for PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT?

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

What is the FDA product code for PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT?

The FDA product code for PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT is DEW.

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 Diagnostica, 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.

K002756EASE-A-CULTK823348H. INFLUENZA B ANTISERA FOR CIEK812434DIAGNOSTIC KITS & KIT COMPONENTSK791281ANTI-HUMAN IGG SERUMK791283ANTI-HUMAN LAMBDA SERUMK791284ANTI-HUMAN KAPPA SERUM

View all 12 devices →

Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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.

↑