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FDA 510(k)

CDL AUTO-LYSING REAGENT

K-Number: K822504 · 1982-09-17

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

Device Summary

CDL AUTO-LYSING REAGENT 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 K822504. 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 CDL AUTO-LYSING REAGENT?

CDL AUTO-LYSING REAGENT 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 K822504.

When did CDL AUTO-LYSING REAGENT receive FDA 510(k) clearance?

CDL AUTO-LYSING REAGENT received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822504.

Who is the listed applicant for CDL AUTO-LYSING REAGENT?

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 AUTO-LYSING REAGENT?

The FDA product code for CDL AUTO-LYSING REAGENT is GGK.

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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 REAGENTK822501CDL ISOTONIC DILUENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENTK801898URIC ACID DIAGNOSTIC REAGENT

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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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