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FDA 510(k)

ASTRA REAGENT CONCENTRATE SYSTEM

K-Number: K812866 · 1981-12-17

ApplicantNobel Scientific Industries, Inc.
Decision Date1981-12-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASTRA REAGENT CONCENTRATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1981-12-17 under 510(k) number K812866. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA REAGENT CONCENTRATE SYSTEM?

ASTRA REAGENT CONCENTRATE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K812866.

When did ASTRA REAGENT CONCENTRATE SYSTEM receive FDA 510(k) clearance?

ASTRA REAGENT CONCENTRATE SYSTEM received FDA 510(k) clearance on 1981-12-17, under 510(k) number K812866.

Who is the listed applicant for ASTRA REAGENT CONCENTRATE SYSTEM?

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

What is the FDA product code for ASTRA REAGENT CONCENTRATE SYSTEM?

The FDA product code for ASTRA REAGENT CONCENTRATE SYSTEM is CGA.

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Other records listing Nobel Scientific Industries, Inc. as applicant

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K854717NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928K854716NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909K854718NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926K850944NSI LYSING-D REAGENT -4000 MLK844782NSI ELT-D DILUTING FLUID 4000MLK823283FLUSHING SOLUTION

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Related Devices (Code: CGA)

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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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