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FDA 510(k)

ACE II (TRI-LEVEL)

K-Number: K863095 · 1986-09-26

ApplicantMedical Analysis Systems, Inc.
Decision Date1986-09-26
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE II (TRI-LEVEL) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K863095. 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 ACE II (TRI-LEVEL)?

ACE II (TRI-LEVEL) is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K863095.

When did ACE II (TRI-LEVEL) receive FDA 510(k) clearance?

ACE II (TRI-LEVEL) received FDA 510(k) clearance on 1986-09-26, under 510(k) number K863095.

Who is the listed applicant for ACE II (TRI-LEVEL)?

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

What is the FDA product code for ACE II (TRI-LEVEL)?

The FDA product code for ACE II (TRI-LEVEL) is JIX.

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Other records listing Medical Analysis Systems, Inc. as applicant

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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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