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FDA 510(k)

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT

K-Number: K810082 · 1981-01-26

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1981-01-26
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-01-26 under 510(k) number K810082. 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 ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT?

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K810082.

When did ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT receive FDA 510(k) clearance?

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810082.

Who is the listed applicant for ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT?

The FDA 510(k) record lists Bio-Analytics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT?

The FDA product code for ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT is CJE.

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Other records listing Bio-Analytics Laboratories, 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT

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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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