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FDA 510(k)

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

K-Number: K862818 · 1986-08-19

ApplicantAmerican Dade
Decision Date1986-08-19
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862818. 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 STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY?

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is American Dade. The 510(k) number is K862818.

When did STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862818.

Who is the listed applicant for STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY?

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

What is the FDA product code for STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY?

The FDA product code for STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY is JJE.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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