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FDA 510(k)

ISOTONIC DILUENT

K-Number: K781008 · 1978-06-28

ApplicantMallinckrodt Critical Care
Decision Date1978-06-28
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ISOTONIC DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1978-06-28 under 510(k) number K781008. 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 ISOTONIC DILUENT?

ISOTONIC DILUENT is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K781008.

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

ISOTONIC DILUENT received FDA 510(k) clearance on 1978-06-28, under 510(k) number K781008.

Who is the listed applicant for ISOTONIC DILUENT?

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

What is the FDA product code for ISOTONIC DILUENT?

The FDA product code for ISOTONIC DILUENT is GIF.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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