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FDA 510(k)

STRATEC LIA II ANALYZER

K-Number: K961142 · 1997-02-18

ApplicantNichols Institute Diagnostics
Decision Date1997-02-18
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATEC LIA II ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1997-02-18 under 510(k) number K961142. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATEC LIA II ANALYZER?

STRATEC LIA II ANALYZER is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K961142.

When did STRATEC LIA II ANALYZER receive FDA 510(k) clearance?

STRATEC LIA II ANALYZER received FDA 510(k) clearance on 1997-02-18, under 510(k) number K961142.

Who is the listed applicant for STRATEC LIA II ANALYZER?

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

What is the FDA product code for STRATEC LIA II ANALYZER?

The FDA product code for STRATEC LIA II ANALYZER is JJE.

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Other records listing Nichols Institute 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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Related Devices (Code: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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