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FDA 510(k)

SPECTROLYSE/PL PAI KIT

K-Number: K922782 · 1992-10-09

ApplicantBiopool AB
Decision Date1992-10-09
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE/PL PAI 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 1992-10-09 under 510(k) number K922782. 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 SPECTROLYSE/PL PAI KIT?

SPECTROLYSE/PL PAI KIT is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is Biopool AB. The 510(k) number is K922782.

When did SPECTROLYSE/PL PAI KIT receive FDA 510(k) clearance?

SPECTROLYSE/PL PAI KIT received FDA 510(k) clearance on 1992-10-09, under 510(k) number K922782.

Who is the listed applicant for SPECTROLYSE/PL PAI 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/PL PAI KIT?

The FDA product code for SPECTROLYSE/PL PAI 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.

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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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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