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FDA 510(k)

OSMOCEL +

K-Number: K830188 · 1983-03-01

ApplicantHematology Marketing Assoc.
Decision Date1983-03-01
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OSMOCEL + 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 1983-03-01 under 510(k) number K830188. 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 +?

OSMOCEL + is a medical device that received FDA 510(k) clearance on 1983-03-01. The listed applicant is Hematology Marketing Assoc.. The 510(k) number is K830188.

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

OSMOCEL + received FDA 510(k) clearance on 1983-03-01, under 510(k) number K830188.

Who is the listed applicant for OSMOCEL +?

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 +?

The FDA product code for OSMOCEL + 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.

K851843OSMOCEL 3K851375TRI-COUNTK850097LASER-LYSEK850096LASER-GLOBINK850095LASER-DILK850094LASER-GLOBIN POWDER

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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.

K883989KVM ISOTONIC FLUSH SOLUTIONKvm Technologies, Inc.K883990KVM ISOTONIC DILUENTKvm 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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