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FDA 510(k)

ACE CLINICAL CHEMISTRY SYSTEM

K-Number: K931786 · 1993-09-21

ApplicantSchiapparelli Biosystems, Inc.
Decision Date1993-09-21
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE CLINICAL CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Schiapparelli Biosystems, Inc.. It received FDA 510(k) clearance on 1993-09-21 under 510(k) number K931786. 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 ACE CLINICAL CHEMISTRY SYSTEM?

ACE CLINICAL CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-21. The listed applicant is Schiapparelli Biosystems, Inc.. The 510(k) number is K931786.

When did ACE CLINICAL CHEMISTRY SYSTEM receive FDA 510(k) clearance?

ACE CLINICAL CHEMISTRY SYSTEM received FDA 510(k) clearance on 1993-09-21, under 510(k) number K931786.

Who is the listed applicant for ACE CLINICAL CHEMISTRY SYSTEM?

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

What is the FDA product code for ACE CLINICAL CHEMISTRY SYSTEM?

The FDA product code for ACE CLINICAL CHEMISTRY SYSTEM is JJE.

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Other records listing Schiapparelli Biosystems, 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.

K991733ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSK981377ACE T4 REAGENT T4 CALIBRATORSK981375ACE T UPTAKE REAGENT TU CALIBRATORSK973582ACE PRIMIDONE REAGENT, AED CALIBRATORSK973581ACE VALPROIC ACID REAGENT, AED CALIBRATORSK973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

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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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