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FDA 510(k)

HEMAQUIK

K-Number: K811400 · 1981-06-18

ApplicantAccra Laboratories, Inc.
Decision Date1981-06-18
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMAQUIK 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 1981-06-18 under 510(k) number K811400. The device is classified under product code IAF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAQUIK?

HEMAQUIK is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K811400.

When did HEMAQUIK receive FDA 510(k) clearance?

HEMAQUIK received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811400.

Who is the listed applicant for HEMAQUIK?

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 HEMAQUIK?

The FDA product code for HEMAQUIK is IAF.

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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.

K851494TWO-STEP ACID FAST BACTERIA STAINK851493KINYOUN ACID FAST STAIN KITK843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6K843425HARRIS HEMATOXYLIN, MERCURY FREE, ACIDK843428BIOFIXK843426EOSIN Y 1% ALCOHOLIC

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Related Devices (Code: IAF)

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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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