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FDA 510(k)

ALBUMIN REAGENT

K-Number: K021636 · 2002-07-17

ApplicantIntersect Systems, Inc.
Decision Date2002-07-17
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 2002-07-17 under 510(k) number K021636. The device is classified under product code CJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN REAGENT?

ALBUMIN REAGENT is a medical device that received FDA 510(k) clearance on 2002-07-17. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K021636.

When did ALBUMIN REAGENT receive FDA 510(k) clearance?

ALBUMIN REAGENT received FDA 510(k) clearance on 2002-07-17, under 510(k) number K021636.

Who is the listed applicant for ALBUMIN REAGENT?

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

What is the FDA product code for ALBUMIN REAGENT?

The FDA product code for ALBUMIN REAGENT is CJW.

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Other records listing Intersect Systems, 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.

K011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENTK941807INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

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Related Devices (Code: CJW)

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.

K203530Albumin BCP2Abbott Ireland Diagnostics DivisionK193001Albumin BCPSENTINEL CH. SpAK132664ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.K000483RANDOX ALBUMINRandox Laboratories, Ltd.K990978ALBUMIN BCG, MODEL AL 103-01A.P. Total Care, Inc.K981814ALBPAbbott Laboratories

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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