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FDA 510(k)

HEMATOLOGY ANALYZER

K-Number: K842310 · 1984-09-06

ApplicantHml Inc/Biotechnology Transfer
Decision Date1984-09-06
Product CodeJKL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hml Inc/Biotechnology Transfer. It received FDA 510(k) clearance on 1984-09-06 under 510(k) number K842310. The device is classified under product code JKL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOLOGY ANALYZER?

HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1984-09-06. The listed applicant is Hml Inc/Biotechnology Transfer. The 510(k) number is K842310.

When did HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1984-09-06, under 510(k) number K842310.

Who is the listed applicant for HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Hml Inc/Biotechnology Transfer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMATOLOGY ANALYZER?

The FDA product code for HEMATOLOGY ANALYZER is JKL.

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 Hml Inc/Biotechnology Transfer 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.

K843000MICRO ORGANISM GROWTH SYS-M1000K842311CHEMISTRY ANALYZER, GEN. PURPOSE

Related Devices (Code: JKL)

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.

K921534DSL DHEA (DSL 8900)Diagnostic Systems Laboratories, Inc.

Official Source

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

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