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FDA 510(k)

CELL-DYN ISOTONIC DILUENT

K-Number: K881130 · 1988-03-31

ApplicantAbbott Diagnostics
Decision Date1988-03-31
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN ISOTONIC DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1988-03-31 under 510(k) number K881130. 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 CELL-DYN ISOTONIC DILUENT?

CELL-DYN ISOTONIC DILUENT is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Abbott Diagnostics. The 510(k) number is K881130.

When did CELL-DYN ISOTONIC DILUENT receive FDA 510(k) clearance?

CELL-DYN ISOTONIC DILUENT received FDA 510(k) clearance on 1988-03-31, under 510(k) number K881130.

Who is the listed applicant for CELL-DYN ISOTONIC DILUENT?

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

What is the FDA product code for CELL-DYN ISOTONIC DILUENT?

The FDA product code for CELL-DYN ISOTONIC DILUENT is GIF.

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Other records listing Abbott Diagnostics 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.

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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.K873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENTAbbott DiagnosticsK851843OSMOCEL 3Hematology Marketing Assoc.

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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