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FDA 510(k)

COMBION SKIN TEST

K-Number: K830688 · 1983-03-31

ApplicantNicholas H. Maganias
Decision Date1983-03-31
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COMBION SKIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nicholas H. Maganias. It received FDA 510(k) clearance on 1983-03-31 under 510(k) number K830688. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBION SKIN TEST?

COMBION SKIN TEST is a medical device that received FDA 510(k) clearance on 1983-03-31. The listed applicant is Nicholas H. Maganias. The 510(k) number is K830688.

When did COMBION SKIN TEST receive FDA 510(k) clearance?

COMBION SKIN TEST received FDA 510(k) clearance on 1983-03-31, under 510(k) number K830688.

Who is the listed applicant for COMBION SKIN TEST?

The FDA 510(k) record lists Nicholas H. Maganias as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBION SKIN TEST?

The FDA product code for COMBION SKIN TEST is LKH.

Related Clinical Trials

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.

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Other records listing Nicholas H. Maganias 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.

K833999COMBION SKIN TEST - FOUR PRONG

Related Devices (Code: LKH)

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.

K910644IPAZYME (TM) CHLAMYDIA IGG-IGASavyon Diagnostics , Ltd.K901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)Savyon Diagnostics , Ltd.K882674IMMU-MARK(TM) CHLAMYDIA IGG/IGA KITIcn ImmunobiologicalsK893669CELLMATICS SHLAMYDIA DETECTION SYSTEMDifco Laboratories, Inc.K852869SELECTICULT-CHLAMYDIAScott Laboratories, Inc.K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITBartels Immunodiagnostic Supplies, 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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