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FDA 510(k)

KM-KAL L6

K-Number: K823023 · 1982-11-16

ApplicantKmn Products, Inc.
Decision Date1982-11-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KM-KAL L6 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 1982-11-16 under 510(k) number K823023. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KM-KAL L6?

KM-KAL L6 is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Kmn Products, Inc.. The 510(k) number is K823023.

When did KM-KAL L6 receive FDA 510(k) clearance?

KM-KAL L6 received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823023.

Who is the listed applicant for KM-KAL L6?

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 L6?

The FDA product code for KM-KAL L6 is JIT.

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 1K823021KM - KAL 5K823020KM-KAL 4K823022KM-KAL 6

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Related Devices (Code: JIT)

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.

K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical DiagnosticsK170938CalSet IGF-1Roche DiagnosticsK170160Abbott ARCHITECT Free T3Abbott LaboratoriesK163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.K163521Lumipulse G LH CalibratorsFujirebio 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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