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FDA 510(k)

ALBUMIN BCP

K-Number: K844426 · 1985-01-07

ApplicantBoehringer Mannheim Corp.
Decision Date1985-01-07
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN BCP is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K844426. 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 BCP?

ALBUMIN BCP is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K844426.

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

ALBUMIN BCP received FDA 510(k) clearance on 1985-01-07, under 510(k) number K844426.

Who is the listed applicant for ALBUMIN BCP?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN BCP?

The FDA product code for ALBUMIN BCP is CJW.

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Other records listing Boehringer Mannheim Corp. 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.

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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.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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