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FDA 510(k)

ABS CADKIT

K-Number: K910636 · 1991-04-29

ApplicantPanbio, Inc.
Decision Date1991-04-29
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABS CADKIT is the device name listed in this FDA 510(k) record. The listed applicant is Panbio, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K910636. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABS CADKIT?

ABS CADKIT is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Panbio, Inc.. The 510(k) number is K910636.

When did ABS CADKIT receive FDA 510(k) clearance?

ABS CADKIT received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910636.

Who is the listed applicant for ABS CADKIT?

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

What is the FDA product code for ABS CADKIT?

The FDA product code for ABS CADKIT is GIS.

Related Clinical Trials

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Other records listing Panbio, 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.

K002024PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXAK970189FIF TMK962176TPP

Related Devices (Code: GIS)

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.

K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetDiazyme LaboratoriesK042919FIBROTEK FIBR2 Diagnostics, Inc.K993482K-ASSAY FIBRINOGENKamiya Biomedical Co.K963902QUANTITATIVE FIBRINOGEN ASSAYOrtho Diagnostic Systems, Inc.K941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITDiagnostic SpecialtiesK925494BIOMERIEUX HEMOLAB FIBRINOMATBiomerieux Vitek, 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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