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FDA 510(k)

KM-KAL L4

K-Number: K823045 · 1982-11-05

ApplicantKmn Products, Inc.
Decision Date1982-11-05
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KM-KAL L4 is the device name listed in this FDA 510(k) record. The listed applicant is Kmn Products, Inc.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K823045. 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 KM-KAL L4?

KM-KAL L4 is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Kmn Products, Inc.. The 510(k) number is K823045.

When did KM-KAL L4 receive FDA 510(k) clearance?

KM-KAL L4 received FDA 510(k) clearance on 1982-11-05, under 510(k) number K823045.

Who is the listed applicant for KM-KAL L4?

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

What is the FDA product code for KM-KAL L4?

The FDA product code for KM-KAL L4 is JIX.

Other records listing Kmn Products, 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.

K823044KM-KAL L3K823025KM - KAL 2K823024KM - KAL 1K823023KM-KAL L6K823021KM - KAL 5K823020KM-KAL 4

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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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