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FDA 510(k)

FTA-ABS BIOPAK

K-Number: K802276 · 1980-10-23

ApplicantBioware Products
Decision Date1980-10-23
Product CodeJWL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FTA-ABS 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 1980-10-23 under 510(k) number K802276. The device is classified under product code JWL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FTA-ABS BIOPAK?

FTA-ABS BIOPAK is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Bioware Products. The 510(k) number is K802276.

When did FTA-ABS BIOPAK receive FDA 510(k) clearance?

FTA-ABS BIOPAK received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802276.

Who is the listed applicant for FTA-ABS 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 FTA-ABS BIOPAK?

The FDA product code for FTA-ABS BIOPAK is JWL.

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 BIOPAKK802308T/K (ATA/AMA) UNIVERSAL BIOPAK

Related Devices (Code: JWL)

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.

K831296POLYCHACO FIA-ABS TEST FOR SYPHILISParasitic Disease ConsultantsK801959FTA-ABS TESTImmuno-Diagnostic Products, Inc.K801928LAB-TEK FTA-ABS KITMiles 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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