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FDA 510(k)

AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN

K-Number: K842328 · 1984-08-03

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-08-03
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN 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 1984-08-03 under 510(k) number K842328. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN?

AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842328.

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

AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842328.

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

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 LAMBDA CHAIN?

The FDA product code for AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN is DEH.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. as applicant

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Related Devices (Code: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, Ltd.

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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