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FDA 510(k)

NA/K FLUIDA PACK FOR NOVA 1 ANALYZER

K-Number: K833712 · 1984-01-13

ApplicantFisher Scientific Co., LLC
Decision Date1984-01-13
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NA/K FLUIDA PACK FOR NOVA 1 ANALYZER 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 1984-01-13 under 510(k) number K833712. 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 NA/K FLUIDA PACK FOR NOVA 1 ANALYZER?

NA/K FLUIDA PACK FOR NOVA 1 ANALYZER is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K833712.

When did NA/K FLUIDA PACK FOR NOVA 1 ANALYZER receive FDA 510(k) clearance?

NA/K FLUIDA PACK FOR NOVA 1 ANALYZER received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833712.

Who is the listed applicant for NA/K FLUIDA PACK FOR NOVA 1 ANALYZER?

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 NA/K FLUIDA PACK FOR NOVA 1 ANALYZER?

The FDA product code for NA/K FLUIDA PACK FOR NOVA 1 ANALYZER is JGS.

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Other records listing Fisher Scientific Co., LLC 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.

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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Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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