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FDA 510(k)

RED CELL LYSING REAGENT 78N 1915-1

K-Number: K822324 · 1982-11-08

ApplicantInterscience, Inc.
Decision Date1982-11-08
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RED CELL LYSING REAGENT 78N 1915-1 is the device name listed in this FDA 510(k) record. The listed applicant is Interscience, Inc.. It received FDA 510(k) clearance on 1982-11-08 under 510(k) number K822324. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED CELL LYSING REAGENT 78N 1915-1?

RED CELL LYSING REAGENT 78N 1915-1 is a medical device that received FDA 510(k) clearance on 1982-11-08. The listed applicant is Interscience, Inc.. The 510(k) number is K822324.

When did RED CELL LYSING REAGENT 78N 1915-1 receive FDA 510(k) clearance?

RED CELL LYSING REAGENT 78N 1915-1 received FDA 510(k) clearance on 1982-11-08, under 510(k) number K822324.

Who is the listed applicant for RED CELL LYSING REAGENT 78N 1915-1?

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 RED CELL LYSING REAGENT 78N 1915-1?

The FDA product code for RED CELL LYSING REAGENT 78N 1915-1 is GGK.

Related Clinical Trials

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.

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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 & HEMOCRITK822325BLOOD CELL DILUENT 78N 1913K822326BLENDED DETERGENT-78N 1912-1

Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, Inc.

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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