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FDA 510(k)

SPECTROLYSE HEPARIN (ANTI-IIA)

K-Number: K972209 · 1997-08-12

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1997-08-12
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE HEPARIN (ANTI-IIA) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K972209. 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 (ANTI-IIA)?

SPECTROLYSE HEPARIN (ANTI-IIA) is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K972209.

When did SPECTROLYSE HEPARIN (ANTI-IIA) receive FDA 510(k) clearance?

SPECTROLYSE HEPARIN (ANTI-IIA) received FDA 510(k) clearance on 1997-08-12, under 510(k) number K972209.

Who is the listed applicant for SPECTROLYSE HEPARIN (ANTI-IIA)?

The FDA 510(k) record lists Medical Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTROLYSE HEPARIN (ANTI-IIA)?

The FDA product code for SPECTROLYSE HEPARIN (ANTI-IIA) is KFF.

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Other records listing Medical Diagnostic Technologies, Inc. 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.

K062229CTC WORKSTATION, MODEL 2200K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KITK961724U-DOA CONTROLS

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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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