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FDA 510(k)

SBA 300 CLINICAL CHEMISTRY ANALYZER

K-Number: K823233 · 1982-11-29

ApplicantGilford Instrument Laboratories, Inc.
Decision Date1982-11-29
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SBA 300 CLINICAL CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Instrument Laboratories, Inc.. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823233. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBA 300 CLINICAL CHEMISTRY ANALYZER?

SBA 300 CLINICAL CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Gilford Instrument Laboratories, Inc.. The 510(k) number is K823233.

When did SBA 300 CLINICAL CHEMISTRY ANALYZER receive FDA 510(k) clearance?

SBA 300 CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823233.

Who is the listed applicant for SBA 300 CLINICAL CHEMISTRY ANALYZER?

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

What is the FDA product code for SBA 300 CLINICAL CHEMISTRY ANALYZER?

The FDA product code for SBA 300 CLINICAL CHEMISTRY ANALYZER is JJC.

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Other records listing Gilford Instrument Laboratories, 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.

K821583AMES/GILFORD OPTIMATE CLIN. CHEM & THERK802609CHEMISTRY ANALYZER IMPACT 400K801889MODEL 203S CLINICAL CHEMISTRY ANALYZERK800085SYSTEM 203 CHEMISTRY ANALYZERK792361SYSTEM 103 CHEMISTRY ANALYZERK792087MICROFLAME PHOTOMETER

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Related Devices (Code: JJC)

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.

K945915AVL OMNI ANALYZERAvl Scientific Corp.K945584NOVA 16 ANALYZERNova Biomedical Corp.K943376OPERA SYSTEMMiles, Inc.K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare CorpK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.

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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