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FDA 510(k)

HEMOCOLOR STAIN SET

K-Number: K810684 · 1981-04-08

ApplicantHarleco
Decision Date1981-04-08
Product CodeICC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCOLOR STAIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-04-08 under 510(k) number K810684. The device is classified under product code ICC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCOLOR STAIN SET?

HEMOCOLOR STAIN SET is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Harleco. The 510(k) number is K810684.

When did HEMOCOLOR STAIN SET receive FDA 510(k) clearance?

HEMOCOLOR STAIN SET received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810684.

Who is the listed applicant for HEMOCOLOR STAIN SET?

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

What is the FDA product code for HEMOCOLOR STAIN SET?

The FDA product code for HEMOCOLOR STAIN SET is ICC.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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