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FDA 510(k)

LYSING AGENT AF

K-Number: K761183 · 1977-01-17

ApplicantCentral Labs. Assoc. MD Pathologists
Decision Date1977-01-17
Product CodeJCE
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

LYSING AGENT AF is the device name listed in this FDA 510(k) record. The listed applicant is Central Labs. Assoc. MD Pathologists. It received FDA 510(k) clearance on 1977-01-17 under 510(k) number K761183. The device is classified under product code JCE. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYSING AGENT AF?

LYSING AGENT AF is a medical device that received FDA 510(k) clearance on 1977-01-17. The listed applicant is Central Labs. Assoc. MD Pathologists. The 510(k) number is K761183.

When did LYSING AGENT AF receive FDA 510(k) clearance?

LYSING AGENT AF received FDA 510(k) clearance on 1977-01-17, under 510(k) number K761183.

Who is the listed applicant for LYSING AGENT AF?

The FDA 510(k) record lists Central Labs. Assoc. MD Pathologists as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYSING AGENT AF?

The FDA product code for LYSING AGENT AF is JCE.

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 Central Labs. Assoc. MD Pathologists 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.

K771201FORMALIN BUFFER CONCENTRATEK761182ISOTONIC DILUENT AF

Related Devices (Code: JCE)

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.

K842722BUFFERED SALINEE K Ind., Inc.K831200IMMUNOHEMATOLOGICAL SALINE #97139Emd Chemicals, Inc.K801506CERTIFIED BLOOD BANK SALINENobel Scientific Industries, Inc.K792101COUITER/CMS ISOTONIC BLOOD BANK SALINECoulter Electronics, Inc.K761170BARBITAL SALINE BUFFERBio/Data Corp.K761174PHYSIOLOGIC SALINE (0.85%)Bio/Data 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.

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