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FDA 510(k)

CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT

K-Number: K842151 · 1984-07-20

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-07-20
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-07-20 under 510(k) number K842151. 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 CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT?

CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842151.

When did CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT receive FDA 510(k) clearance?

CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842151.

Who is the listed applicant for CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT?

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

What is the FDA product code for CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT?

The FDA product code for CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT is LKH.

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Other records listing Bartels Immunodiagnostic Supplies, 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.

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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.K830688COMBION SKIN TESTNicholas H. Maganias

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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