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FDA 510(k)

SPECTROLYSE HEPARIN KIT

K-Number: K923499 · 1994-01-27

ApplicantBiopool AB
Decision Date1994-01-27
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE HEPARIN 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 1994-01-27 under 510(k) number K923499. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTROLYSE HEPARIN KIT?

SPECTROLYSE HEPARIN KIT is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Biopool AB. The 510(k) number is K923499.

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

SPECTROLYSE HEPARIN KIT received FDA 510(k) clearance on 1994-01-27, under 510(k) number K923499.

Who is the listed applicant for SPECTROLYSE HEPARIN 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 HEPARIN KIT?

The FDA product code for SPECTROLYSE HEPARIN KIT is KFF.

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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) TPAK932463BIOCLOT LAK920668MINUTEX D-DIMER LATEX TESTK922782SPECTROLYSE/PL PAI KIT

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Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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