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FDA 510(k)

GENZYME DIAGNOSTICS CONTRAST MONO

K-Number: K963425 · 1997-02-25

ApplicantGenzyme Diagnostics
Decision Date1997-02-25
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GENZYME DIAGNOSTICS CONTRAST MONO is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Diagnostics. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K963425. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENZYME DIAGNOSTICS CONTRAST MONO?

GENZYME DIAGNOSTICS CONTRAST MONO is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Genzyme Diagnostics. The 510(k) number is K963425.

When did GENZYME DIAGNOSTICS CONTRAST MONO receive FDA 510(k) clearance?

GENZYME DIAGNOSTICS CONTRAST MONO received FDA 510(k) clearance on 1997-02-25, under 510(k) number K963425.

Who is the listed applicant for GENZYME DIAGNOSTICS CONTRAST MONO?

The FDA 510(k) record lists Genzyme Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENZYME DIAGNOSTICS CONTRAST MONO?

The FDA product code for GENZYME DIAGNOSTICS CONTRAST MONO is KTN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Genzyme Diagnostics 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.

K043385OSOM HCG COMBO TESTK983399GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYK964156CONTRAST STRIP HCGK964155CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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