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FDA 510(k)

CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN

K-Number: K792339 · 1979-12-06

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1979-12-06
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN 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 1979-12-06 under 510(k) number K792339. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN?

CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K792339.

When did CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN receive FDA 510(k) clearance?

CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792339.

Who is the listed applicant for CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN?

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 CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN?

The FDA product code for CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN is CIX.

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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 DILUENTK822504CDL AUTO-LYSING REAGENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENT

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Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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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