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)

EZ COMPLEMENT REAGENTS, 78N2212

K-Number: K870351 · 1987-03-13

ApplicantDiamedix Corp.
Decision Date1987-03-13
Product CodeDHL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EZ COMPLEMENT REAGENTS, 78N2212 is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K870351. The device is classified under product code DHL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ COMPLEMENT REAGENTS, 78N2212?

EZ COMPLEMENT REAGENTS, 78N2212 is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Diamedix Corp.. The 510(k) number is K870351.

When did EZ COMPLEMENT REAGENTS, 78N2212 receive FDA 510(k) clearance?

EZ COMPLEMENT REAGENTS, 78N2212 received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870351.

Who is the listed applicant for EZ COMPLEMENT REAGENTS, 78N2212?

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

What is the FDA product code for EZ COMPLEMENT REAGENTS, 78N2212?

The FDA product code for EZ COMPLEMENT REAGENTS, 78N2212 is DHL.

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 Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

View all 68 devices →

Related Devices (Code: DHL)

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.

K811445KALLESTAD R QUANTIPLATE ALT. PATHWAY T.Kallestad Laboratories, Inc.K811433SCRIPPSERA COMPLEMENT CONTROL SERAScripps-Miles, Inc.K770866RABBIT COMPLEMENTCedarlake Labs , Ltd.

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.

↑