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FDA 510(k)

ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR

K-Number: K904767 · 1990-12-26

ApplicantAnalytical Control Systems, Inc.
Decision Date1990-12-26
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K904767. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR?

ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K904767.

When did ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR receive FDA 510(k) clearance?

ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR received FDA 510(k) clearance on 1990-12-26, under 510(k) number K904767.

Who is the listed applicant for ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR?

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

What is the FDA product code for ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR?

The FDA product code for ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR is JIX.

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Other records listing Analytical Control Systems, 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.

K961892SPECKTIN-LA TEST SETK941115ACS CARDIO-TROL CONTROLK940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLK940397ACS O DILVENT PROTEIN DILUTION MATRIXK930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORK926012ACS APCT REAGENT, MODIFIED

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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