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FDA 510(k)

ALBUMIN PROCEDURE BCP

K-Number: K832632 · 1983-09-12

ApplicantSandare Chemical Co., Inc.
Decision Date1983-09-12
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN PROCEDURE BCP 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 1983-09-12 under 510(k) number K832632. 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 PROCEDURE BCP?

ALBUMIN PROCEDURE BCP is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K832632.

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

ALBUMIN PROCEDURE BCP received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832632.

Who is the listed applicant for ALBUMIN PROCEDURE BCP?

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 ALBUMIN PROCEDURE BCP?

The FDA product code for ALBUMIN PROCEDURE BCP is CJW.

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Other records listing Sandare Chemical Co., Inc. as applicant

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Related Devices (Code: CJW)

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K203530Albumin BCP2Abbott Ireland Diagnostics DivisionK193001Albumin BCPSENTINEL CH. SpAK132664ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATORSiemens Healthcare Diagnostics, Inc.K021636ALBUMIN REAGENTIntersect Systems, Inc.K000483RANDOX ALBUMINRandox Laboratories, Ltd.K990978ALBUMIN BCG, MODEL AL 103-01A.P. Total Care, 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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