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FDA 510(k)

HARRIS HEMATOXYLIN

K-Number: K823328 · 1982-12-28

ApplicantAccra Laboratories, Inc.
Decision Date1982-12-28
Product CodeHYK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HARRIS HEMATOXYLIN is the device name listed in this FDA 510(k) record. The listed applicant is Accra Laboratories, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823328. The device is classified under product code HYK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARRIS HEMATOXYLIN?

HARRIS HEMATOXYLIN is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K823328.

When did HARRIS HEMATOXYLIN receive FDA 510(k) clearance?

HARRIS HEMATOXYLIN received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823328.

Who is the listed applicant for HARRIS HEMATOXYLIN?

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

What is the FDA product code for HARRIS HEMATOXYLIN?

The FDA product code for HARRIS HEMATOXYLIN is HYK.

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Other records listing Accra Laboratories, 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.

K851493KINYOUN ACID FAST STAIN KITK851494TWO-STEP ACID FAST BACTERIA STAINK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

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Related Devices (Code: HYK)

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.

K873107INSTANT HEMATOXYLINShandon, Inc.K872498HARRIS HEMATOXYLINAnatech, Ltd.K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDAccra Laboratories, Inc.K810733HARRIS HEMATOXYLINSurgipathK800324VOLU-SOL HARRIS HEMATOXYLINVolu Sol Medical IndustriesK781585HEMATOXYLIN STAIN HARRISBioscientific

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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