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)

TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH

K-Number: K850250 · 1985-04-01

ApplicantTechnicon Instruments Corp.
Decision Date1985-04-01
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1985-04-01 under 510(k) number K850250. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH?

TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH is a medical device that received FDA 510(k) clearance on 1985-04-01. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K850250.

When did TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH receive FDA 510(k) clearance?

TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH received FDA 510(k) clearance on 1985-04-01, under 510(k) number K850250.

Who is the listed applicant for TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH?

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

What is the FDA product code for TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH?

The FDA product code for TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH is JPK.

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 Technicon Instruments 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.

K914888TECHNICON CHEM 1(TM) SYST (GEN2 SYST)K914511TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOLK914025TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)K912616TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTESK912413CHEM-LINK DATA BASE MANAGERK903824DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY

View all 157 devices →

Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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.

↑