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FDA 510(k)

TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL

K-Number: K922722 · 1992-10-05

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

Device Summary

TECH DIMPLE C-REACTIVE PROTEIN 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 K922722. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL?

TECH DIMPLE C-REACTIVE PROTEIN 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 K922722.

When did TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL receive FDA 510(k) clearance?

TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL received FDA 510(k) clearance on 1992-10-05, under 510(k) number K922722.

Who is the listed applicant for TECH DIMPLE C-REACTIVE PROTEIN 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 DIMPLE C-REACTIVE PROTEIN SERUM CONTROL?

The FDA product code for TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL is DCK.

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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 CONTROLK922726TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROLK922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROLK922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

Official Source

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