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FDA 510(k)

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95

K-Number: K871638 · 1987-05-12

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-05-12
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K871638. 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 EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95?

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K871638.

When did EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 receive FDA 510(k) clearance?

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 received FDA 510(k) clearance on 1987-05-12, under 510(k) number K871638.

Who is the listed applicant for EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95?

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

What is the FDA product code for EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95?

The FDA product code for EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 is JIX.

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Other records listing Em Diagnostic 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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