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FDA 510(k)

HEMAQUIK II STAINING SOLUTION #55961

K-Number: K830542 · 1983-03-17

ApplicantAccra Laboratories, Inc.
Decision Date1983-03-17
Product CodeIAF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMAQUIK II STAINING SOLUTION #55961 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 1983-03-17 under 510(k) number K830542. 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 II STAINING SOLUTION #55961?

HEMAQUIK II STAINING SOLUTION #55961 is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Accra Laboratories, Inc.. The 510(k) number is K830542.

When did HEMAQUIK II STAINING SOLUTION #55961 receive FDA 510(k) clearance?

HEMAQUIK II STAINING SOLUTION #55961 received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830542.

Who is the listed applicant for HEMAQUIK II STAINING SOLUTION #55961?

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 II STAINING SOLUTION #55961?

The FDA product code for HEMAQUIK II STAINING SOLUTION #55961 is IAF.

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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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