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FDA 510(k)

BIOPOOL PROTEIN C EID KIT AND BULK PLATES

K-Number: K902566 · 1990-08-09

ApplicantBiopool AB
Decision Date1990-08-09
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOPOOL PROTEIN C EID KIT AND 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 1990-08-09 under 510(k) number K902566. 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 PROTEIN C EID KIT AND BULK PLATES?

BIOPOOL PROTEIN C EID KIT AND BULK PLATES is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Biopool AB. The 510(k) number is K902566.

When did BIOPOOL PROTEIN C EID KIT AND BULK PLATES receive FDA 510(k) clearance?

BIOPOOL PROTEIN C EID KIT AND BULK PLATES received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902566.

Who is the listed applicant for BIOPOOL PROTEIN C EID KIT AND 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 PROTEIN C EID KIT AND BULK PLATES?

The FDA product code for BIOPOOL PROTEIN C EID KIT AND 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.

K941752SPECTROLYSE ANTIPLASMIN KITK942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATESK934314TINTELIZER(R) TPAK923499SPECTROLYSE HEPARIN KITK932463BIOCLOT LAK920668MINUTEX D-DIMER LATEX TEST

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Related Devices (Code: GGP)

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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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