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FDA 510(k)

T/K (ATA/AMA) UNIVERSAL BIOPAK

K-Number: K802308 · 1980-12-01

ApplicantBioware Products
Decision Date1980-12-01
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

T/K (ATA/AMA) 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 1980-12-01 under 510(k) number K802308. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T/K (ATA/AMA) UNIVERSAL BIOPAK?

T/K (ATA/AMA) UNIVERSAL BIOPAK is a medical device that received FDA 510(k) clearance on 1980-12-01. The listed applicant is Bioware Products. The 510(k) number is K802308.

When did T/K (ATA/AMA) UNIVERSAL BIOPAK receive FDA 510(k) clearance?

T/K (ATA/AMA) UNIVERSAL BIOPAK received FDA 510(k) clearance on 1980-12-01, under 510(k) number K802308.

Who is the listed applicant for T/K (ATA/AMA) 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 T/K (ATA/AMA) UNIVERSAL BIOPAK?

The FDA product code for T/K (ATA/AMA) UNIVERSAL BIOPAK is DBM.

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 GELK802299K/K (ASMA/ANA) UNIVERSAL BIOPAKK802276FTA-ABS BIOPAK

Related Devices (Code: DBM)

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.

K181556EliA M2 ImmunoassayPhadia ABK163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K092736EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K052262QUANTA LITE M2 EP (MIT3) ELISAInova Diagnostics, Inc.K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760Rhigene, 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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