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FDA 510(k)

OSMOCEL 3

K-Number: K851843 · 1985-07-30

ApplicantHematology Marketing Assoc.
Decision Date1985-07-30
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OSMOCEL 3 is the device name listed in this FDA 510(k) record. The listed applicant is Hematology Marketing Assoc.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K851843. 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 OSMOCEL 3?

OSMOCEL 3 is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K851843.

When did OSMOCEL 3 receive FDA 510(k) clearance?

OSMOCEL 3 received FDA 510(k) clearance on 1985-07-30, under 510(k) number K851843.

Who is the listed applicant for OSMOCEL 3?

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

What is the FDA product code for OSMOCEL 3?

The FDA product code for OSMOCEL 3 is GIF.

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Other records listing Hematology Marketing Assoc. 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.

K851375TRI-COUNTK850094LASER-GLOBIN POWDERK850095LASER-DILK850097LASER-LYSEK850096LASER-GLOBINK844708TRI-COUNT CALIBRATOR

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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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