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FDA 510(k)

IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS

K-Number: K852676 · 1985-07-22

ApplicantAllied Instrumentation Laboratory
Decision Date1985-07-22
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Allied Instrumentation Laboratory. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K852676. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS?

IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Allied Instrumentation Laboratory. The 510(k) number is K852676.

When did IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS receive FDA 510(k) clearance?

IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852676.

Who is the listed applicant for IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS?

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

What is the FDA product code for IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS?

The FDA product code for IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS is CHL.

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Other records listing Allied Instrumentation Laboratory 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.

K861901MULTI-4 CO-OXIMETER CONTROLK860365PHENOBARBITAL TEST SYSTEMK860286IL TEST PHENYTOINK853858IL TEST THEOPHYLLINE ASSAYK851933CLINICAL CHEMISTRY ANALYTICAL SYSTEMK850748I-L TEST, DIRECT BILIRUBIN SET

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Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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