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FDA 510(k)

K/K (ASMA/ANA) UNIVERSAL BIOPAK

K-Number: K802299 · 1981-01-29

ApplicantBioware Products
Decision Date1981-01-29
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

K/K (ASMA/ANA) UNIVERSAL BIOPAK is the device name listed in this FDA 510(k) record. The listed applicant is Bioware Products. It received FDA 510(k) clearance on 1981-01-29 under 510(k) number K802299. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K/K (ASMA/ANA) UNIVERSAL BIOPAK?

K/K (ASMA/ANA) UNIVERSAL BIOPAK is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Bioware Products. The 510(k) number is K802299.

When did K/K (ASMA/ANA) UNIVERSAL BIOPAK receive FDA 510(k) clearance?

K/K (ASMA/ANA) UNIVERSAL BIOPAK received FDA 510(k) clearance on 1981-01-29, under 510(k) number K802299.

Who is the listed applicant for K/K (ASMA/ANA) UNIVERSAL BIOPAK?

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

What is the FDA product code for K/K (ASMA/ANA) UNIVERSAL BIOPAK?

The FDA product code for K/K (ASMA/ANA) UNIVERSAL BIOPAK is DHN.

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 Bioware Products 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.

K810144ALK-PHOS BIOPAK GELK802308T/K (ATA/AMA) UNIVERSAL BIOPAKK802276FTA-ABS BIOPAK

Related Devices (Code: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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