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FDA 510(k)

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT

K-Number: K855034 · 1986-03-11

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1986-03-11
Product CodeLIJ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT 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 1986-03-11 under 510(k) number K855034. The device is classified under product code LIJ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT?

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT is a medical device that received FDA 510(k) clearance on 1986-03-11. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K855034.

When did AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT receive FDA 510(k) clearance?

AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT received FDA 510(k) clearance on 1986-03-11, under 510(k) number K855034.

Who is the listed applicant for AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT?

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 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT?

The FDA product code for AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT is LIJ.

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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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