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FDA 510(k)

SPECTRO VWF

K-Number: K861159 · 1986-05-01

ApplicantRamco Laboratories, Inc.
Decision Date1986-05-01
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTRO VWF is the device name listed in this FDA 510(k) record. The listed applicant is Ramco Laboratories, Inc.. It received FDA 510(k) clearance on 1986-05-01 under 510(k) number K861159. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRO VWF?

SPECTRO VWF is a medical device that received FDA 510(k) clearance on 1986-05-01. The listed applicant is Ramco Laboratories, Inc.. The 510(k) number is K861159.

When did SPECTRO VWF receive FDA 510(k) clearance?

SPECTRO VWF received FDA 510(k) clearance on 1986-05-01, under 510(k) number K861159.

Who is the listed applicant for SPECTRO VWF?

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

What is the FDA product code for SPECTRO VWF?

The FDA product code for SPECTRO VWF is GGP.

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Other records listing Ramco Laboratories, 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.

K983107VFEK981208TFRK910481EPO-RIAK872941SPECTRO CK864701VWF IMMUNOBLOTK831470PTH MR

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Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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