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)

ACE COLOR TEST

K-Number: K833933 · 1984-03-23

ApplicantHana Biologics, Inc.
Decision Date1984-03-23
Product CodeKQN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE COLOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hana Biologics, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K833933. The device is classified under product code KQN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE COLOR TEST?

ACE COLOR TEST is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K833933.

When did ACE COLOR TEST receive FDA 510(k) clearance?

ACE COLOR TEST received FDA 510(k) clearance on 1984-03-23, under 510(k) number K833933.

Who is the listed applicant for ACE COLOR TEST?

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

What is the FDA product code for ACE COLOR TEST?

The FDA product code for ACE COLOR TEST is KQN.

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 Hana Biologics, 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.

K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEMK834616AMNIO STAT-FLM AGGLUTINATION TESTK822737MYCOTRIUM-RSK822736MYCOTRIUM-GUK822150AMNISTAT-FLM

View all 8 devices →

Related Devices (Code: KQN)

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.

K041657THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENTThermo Electron CorporationK942497ANGIOTENSIN CONVERTING ENZYME REAAmerican Laboratory Products Co., Ltd.K913091BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYAmerican Laboratory Products Co., Ltd.K854876ALDOSTERONE DIRECT RIA KITBiotecx Laboratories, Inc.K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVSigma Diagnostics, Inc.K821011ACE ACTIVITY MICROVIAL TEST SETVentrex Laboratories, Inc.

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.

↑