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FDA 510(k)

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT

K-Number: K904761 · 1990-11-20

ApplicantInstrumentation Laboratory CO
Decision Date1990-11-20
Product CodeCIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904761. The device is classified under product code CIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT?

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K904761.

When did P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT receive FDA 510(k) clearance?

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904761.

Who is the listed applicant for P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT?

The FDA product code for P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT is CIE.

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Related Devices (Code: CIE)

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.

K880967MICRO CO2 APPARATUSHf Scientific, Inc.K864313CO2 REAGENT SETHf Scientific, Inc.K832071TOTAL CO2 REAGENT SETAmerican Research Products Co.K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.K800524SERALYZER REFLECTANCE PHOTOMETER/CALIB.Miles Laboratories, Inc.K771610CARBON DIOXIDE ANALYZERCorning Medical & Scientific

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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