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FDA 510(k)

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.

K-Number: K880795 · 1988-04-18

ApplicantTrace America, Inc.
Decision Date1988-04-18
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880795. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.?

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Trace America, Inc.. The 510(k) number is K880795.

When did RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. receive FDA 510(k) clearance?

RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880795.

Who is the listed applicant for RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.?

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

What is the FDA product code for RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.?

The FDA product code for RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. is CJE.

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Other records listing Trace America, 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.

K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K973869TRACE REAGENT LINE FOR THE COBAS MIRAK974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

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Related Devices (Code: CJE)

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.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

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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