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FDA 510(k)

BLOOD CELL DILUENT 78N 1913

K-Number: K822325 · 1982-10-18

ApplicantInterscience, Inc.
Decision Date1982-10-18
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLOOD CELL DILUENT 78N 1913 is the device name listed in this FDA 510(k) record. The listed applicant is Interscience, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822325. 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 BLOOD CELL DILUENT 78N 1913?

BLOOD CELL DILUENT 78N 1913 is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Interscience, Inc.. The 510(k) number is K822325.

When did BLOOD CELL DILUENT 78N 1913 receive FDA 510(k) clearance?

BLOOD CELL DILUENT 78N 1913 received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822325.

Who is the listed applicant for BLOOD CELL DILUENT 78N 1913?

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

What is the FDA product code for BLOOD CELL DILUENT 78N 1913?

The FDA product code for BLOOD CELL DILUENT 78N 1913 is GIF.

Related Clinical Trials

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Other records listing Interscience, Inc. 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.

K822327CALIBRATOR FOR HEMOGLOBIN & HEMOCRITK822324RED CELL LYSING REAGENT 78N 1915-1K822326BLENDED DETERGENT-78N 1912-1

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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