FDA 510(k)

SPECTROLYSE ATIII KIT

K-Number: K902530 · 1990-08-09

Decision Date1990-08-09

Product CodeJBQ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE ATIII 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 1990-08-09 under 510(k) number K902530. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTROLYSE ATIII KIT?

SPECTROLYSE ATIII KIT 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 K902530.

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

SPECTROLYSE ATIII KIT received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902530.

Who is the listed applicant for SPECTROLYSE ATIII 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 ATIII KIT?

The FDA product code for SPECTROLYSE ATIII KIT is JBQ.

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Other records listing Biopool AB as applicant

K941752SPECTROLYSE ANTIPLASMIN KIT K942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES K934314TINTELIZER(R) TPA K923499SPECTROLYSE HEPARIN KIT K932463BIOCLOT LA K920668MINUTEX D-DIMER LATEX TEST

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Related Devices (Code: JBQ)

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics K070301HEMOSIL ANTITHROMBINInstrumentation Laboratory CO K062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen Biomed K033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation 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.