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FDA 510(k)

ALBUMIN BCG, MODEL AL 103-01

K-Number: K990978 · 1999-05-25

ApplicantA.P. Total Care, Inc.
Decision Date1999-05-25
Product CodeCJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN BCG, MODEL AL 103-01 is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-05-25 under 510(k) number K990978. 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 BCG, MODEL AL 103-01?

ALBUMIN BCG, MODEL AL 103-01 is a medical device that received FDA 510(k) clearance on 1999-05-25. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K990978.

When did ALBUMIN BCG, MODEL AL 103-01 receive FDA 510(k) clearance?

ALBUMIN BCG, MODEL AL 103-01 received FDA 510(k) clearance on 1999-05-25, under 510(k) number K990978.

Who is the listed applicant for ALBUMIN BCG, MODEL AL 103-01?

The FDA 510(k) record lists A.P. Total Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALBUMIN BCG, MODEL AL 103-01?

The FDA product code for ALBUMIN BCG, MODEL AL 103-01 is CJW.

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Other records listing A.P. Total Care, 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.

K991246FRUCTOSAMINE, MODEL FR 106-01K991761MAGNESIUM PRODUCT NO'S, 112-01, 112-02K991762ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02K991664LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01K991665HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01K991867INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02

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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.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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