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FDA 510(k)

AMER. HISTO-ID SYS PRIMARY KIT

K-Number: K842326 · 1984-08-02

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-08-02
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMER. HISTO-ID SYS PRIMARY 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 1984-08-02 under 510(k) number K842326. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. HISTO-ID SYS PRIMARY KIT?

AMER. HISTO-ID SYS PRIMARY KIT is a medical device that received FDA 510(k) clearance on 1984-08-02. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842326.

When did AMER. HISTO-ID SYS PRIMARY KIT receive FDA 510(k) clearance?

AMER. HISTO-ID SYS PRIMARY KIT received FDA 510(k) clearance on 1984-08-02, under 510(k) number K842326.

Who is the listed applicant for AMER. HISTO-ID SYS PRIMARY 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 AMER. HISTO-ID SYS PRIMARY KIT?

The FDA product code for AMER. HISTO-ID SYS PRIMARY KIT is DFH.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: DFH)

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.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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