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FDA 510(k)

CDL ISOTONIC DILUENT

K-Number: K822501 · 1982-09-17

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1982-09-17
Product CodeGIF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CDL ISOTONIC DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Connecticut Diagnostics, Ltd.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822501. 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 CDL ISOTONIC DILUENT?

CDL ISOTONIC DILUENT is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K822501.

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

CDL ISOTONIC DILUENT received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822501.

Who is the listed applicant for CDL ISOTONIC DILUENT?

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

What is the FDA product code for CDL ISOTONIC DILUENT?

The FDA product code for CDL ISOTONIC DILUENT is GIF.

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Other records listing Connecticut Diagnostics, Ltd. 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.

K905617VISI-STAPHK822500CDL LYSING REAGENTK822504CDL AUTO-LYSING REAGENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENTK801898URIC ACID DIAGNOSTIC REAGENT

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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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