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FDA 510(k)

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.

K-Number: K871543 · 1987-06-22

ApplicantCatachem, Inc.
Decision Date1987-06-22
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1987-06-22 under 510(k) number K871543. 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 PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.?

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. is a medical device that received FDA 510(k) clearance on 1987-06-22. The listed applicant is Catachem, Inc.. The 510(k) number is K871543.

When did ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. received FDA 510(k) clearance on 1987-06-22, under 510(k) number K871543.

Who is the listed applicant for ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.?

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

What is the FDA product code for ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.?

The FDA product code for ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. is CJE.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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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