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FDA 510(k)

SPECTROLYSE ANTIPLASMIN KIT

K-Number: K941752 · 1995-09-25

ApplicantBiopool AB
Decision Date1995-09-25
Product CodeGGP
Advisory CommitteeHE
DecisionUnknown

Device Summary

SPECTROLYSE ANTIPLASMIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biopool AB. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K941752. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPECTROLYSE ANTIPLASMIN KIT?

SPECTROLYSE ANTIPLASMIN KIT is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is Biopool AB. The 510(k) number is K941752.

When did SPECTROLYSE ANTIPLASMIN KIT receive FDA 510(k) clearance?

SPECTROLYSE ANTIPLASMIN KIT received FDA 510(k) clearance on 1995-09-25, under 510(k) number K941752.

Who is the listed applicant for SPECTROLYSE ANTIPLASMIN KIT?

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 SPECTROLYSE ANTIPLASMIN KIT?

The FDA product code for SPECTROLYSE ANTIPLASMIN KIT 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.

K942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATESK934314TINTELIZER(R) TPAK923499SPECTROLYSE HEPARIN KITK932463BIOCLOT LAK920668MINUTEX D-DIMER LATEX TESTK922782SPECTROLYSE/PL PAI KIT

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Related Devices (Code: GGP)

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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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