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FDA 510(k)

DEAE-DEXTRAN IN PBS

K-Number: K834116 · 1984-04-20

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-04-20
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DEAE-DEXTRAN IN PBS 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 1984-04-20 under 510(k) number K834116. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEAE-DEXTRAN IN PBS?

DEAE-DEXTRAN IN PBS is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K834116.

When did DEAE-DEXTRAN IN PBS receive FDA 510(k) clearance?

DEAE-DEXTRAN IN PBS received FDA 510(k) clearance on 1984-04-20, under 510(k) number K834116.

Who is the listed applicant for DEAE-DEXTRAN IN PBS?

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 DEAE-DEXTRAN IN PBS?

The FDA product code for DEAE-DEXTRAN IN PBS is KIT.

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Related Devices (Code: KIT)

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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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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