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FDA 510(k)

UNITIZED HEMATOLOGY SET 65132/93

K-Number: K840477 · 1984-03-05

ApplicantEmd Chemicals, Inc.
Decision Date1984-03-05
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNITIZED HEMATOLOGY SET 65132/93 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K840477. The device is classified under product code GIF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITIZED HEMATOLOGY SET 65132/93?

UNITIZED HEMATOLOGY SET 65132/93 is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K840477.

When did UNITIZED HEMATOLOGY SET 65132/93 receive FDA 510(k) clearance?

UNITIZED HEMATOLOGY SET 65132/93 received FDA 510(k) clearance on 1984-03-05, under 510(k) number K840477.

Who is the listed applicant for UNITIZED HEMATOLOGY SET 65132/93?

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

What is the FDA product code for UNITIZED HEMATOLOGY SET 65132/93?

The FDA product code for UNITIZED HEMATOLOGY SET 65132/93 is GIF.

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Other records listing Emd Chemicals, Inc. as applicant

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Related Devices (Code: GIF)

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.

K883990KVM ISOTONIC DILUENTKvm Technologies, Inc.K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENTR&D Systems, Inc.K882267SYSMEX QUICKLYSER-II (QLS-200A)Toa Medical Electronics USA, Inc.K881130CELL-DYN ISOTONIC DILUENTAbbott DiagnosticsK873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott Diagnostics

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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