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FDA 510(k)

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES

K-Number: K942087 · 1995-07-13

ApplicantBiopool AB
Decision Date1995-07-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Biopool AB. It received FDA 510(k) clearance on 1995-07-13 under 510(k) number K942087. 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 BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES?

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Biopool AB. The 510(k) number is K942087.

When did BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES receive FDA 510(k) clearance?

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES received FDA 510(k) clearance on 1995-07-13, under 510(k) number K942087.

Who is the listed applicant for BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES?

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

What is the FDA product code for BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES?

The FDA product code for BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES is GGP.

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Other records listing Biopool AB 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.

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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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