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FDA 510(k)

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET

K-Number: K862256 · 1986-07-01

ApplicantSterling Diagnostics, Inc.
Decision Date1986-07-01
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K862256. 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 (PNPP RATE) REAGENT SET?

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K862256.

When did ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862256.

Who is the listed applicant for ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET?

The FDA product code for ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET is CJE.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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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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