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FDA 510(k)

ALBP

K-Number: K981814 · 1998-07-22

ApplicantAbbott Laboratories
Decision Date1998-07-22
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-07-22 under 510(k) number K981814. 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 ALBP?

ALBP is a medical device that received FDA 510(k) clearance on 1998-07-22. The listed applicant is Abbott Laboratories. The 510(k) number is K981814.

When did ALBP receive FDA 510(k) clearance?

ALBP received FDA 510(k) clearance on 1998-07-22, under 510(k) number K981814.

Who is the listed applicant for ALBP?

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

What is the FDA product code for ALBP?

The FDA product code for ALBP is CJW.

Other records listing Abbott Laboratories as applicant

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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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