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FDA 510(k)

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL

K-Number: K922726 · 1992-10-05

ApplicantSimplicity Diagnostics, Inc.
Decision Date1992-10-05
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Simplicity Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K922726. 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 TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL?

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Simplicity Diagnostics, Inc.. The 510(k) number is K922726.

When did TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL receive FDA 510(k) clearance?

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL received FDA 510(k) clearance on 1992-10-05, under 510(k) number K922726.

Who is the listed applicant for TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL?

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

What is the FDA product code for TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL?

The FDA product code for TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL 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 Simplicity Diagnostics, 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.

K970100TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLK922722TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROLK922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROLK922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

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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