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FDA 510(k)

SANDARE BCG ALBUMIN PROCEDURE

K-Number: K860684 · 1986-03-17

ApplicantSandare Chemical Co., Inc.
Decision Date1986-03-17
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANDARE BCG ALBUMIN PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K860684. 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 SANDARE BCG ALBUMIN PROCEDURE?

SANDARE BCG ALBUMIN PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K860684.

When did SANDARE BCG ALBUMIN PROCEDURE receive FDA 510(k) clearance?

SANDARE BCG ALBUMIN PROCEDURE received FDA 510(k) clearance on 1986-03-17, under 510(k) number K860684.

Who is the listed applicant for SANDARE BCG ALBUMIN PROCEDURE?

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

What is the FDA product code for SANDARE BCG ALBUMIN PROCEDURE?

The FDA product code for SANDARE BCG ALBUMIN PROCEDURE is CIX.

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Other records listing Sandare Chemical Co., 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDUREK842516SANDARE ACID PHOSPHATASE PROCEDURE

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Related Devices (Code: CIX)

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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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