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FDA 510(k)

STA-VWF CALIBRATOR KIT

K-Number: K962671 · 1996-09-13

ApplicantAmerican Bioproducts Co.
Decision Date1996-09-13
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA-VWF CALIBRATOR 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 1996-09-13 under 510(k) number K962671. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-VWF CALIBRATOR KIT?

STA-VWF CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 1996-09-13. The listed applicant is American Bioproducts Co.. The 510(k) number is K962671.

When did STA-VWF CALIBRATOR KIT receive FDA 510(k) clearance?

STA-VWF CALIBRATOR KIT received FDA 510(k) clearance on 1996-09-13, under 510(k) number K962671.

Who is the listed applicant for STA-VWF CALIBRATOR 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-VWF CALIBRATOR KIT?

The FDA product code for STA-VWF CALIBRATOR KIT is GJT.

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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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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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