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FDA 510(k)

STA SYSTEM CONTROL [N] + [P] KIT

K-Number: K943518 · 1995-03-21

ApplicantAmerican Bioproducts Co.
Decision Date1995-03-21
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA SYSTEM CONTROL [N] + [P] KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K943518. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA SYSTEM CONTROL [N] + [P] KIT?

STA SYSTEM CONTROL [N] + [P] KIT is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is American Bioproducts Co.. The 510(k) number is K943518.

When did STA SYSTEM CONTROL [N] + [P] KIT receive FDA 510(k) clearance?

STA SYSTEM CONTROL [N] + [P] KIT received FDA 510(k) clearance on 1995-03-21, under 510(k) number K943518.

Who is the listed applicant for STA SYSTEM CONTROL [N] + [P] KIT?

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

What is the FDA product code for STA SYSTEM CONTROL [N] + [P] KIT?

The FDA product code for STA SYSTEM CONTROL [N] + [P] KIT is GGN.

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Other records listing American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: GGN)

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.

K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLCK163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLCK161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc.K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLCK152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLCK150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, 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.

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