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FDA 510(k)

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ

K-Number: K843452 · 1984-09-27

ApplicantFisher Scientific Co., LLC
Decision Date1984-09-27
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1984-09-27 under 510(k) number K843452. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ?

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ is a medical device that received FDA 510(k) clearance on 1984-09-27. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K843452.

When did STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ receive FDA 510(k) clearance?

STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ received FDA 510(k) clearance on 1984-09-27, under 510(k) number K843452.

Who is the listed applicant for STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ?

The FDA product code for STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ is JGS.

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Other records listing Fisher Scientific Co., LLC as applicant

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K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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