FDA 510(k)

CHLORIDE REAGENT

K-Number: K852169 · 1985-08-21

Decision Date1985-08-21

Product CodeCHJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CHLORIDE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852169. The device is classified under product code CHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLORIDE REAGENT?

CHLORIDE REAGENT is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K852169.

When did CHLORIDE REAGENT receive FDA 510(k) clearance?

CHLORIDE REAGENT received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852169.

Who is the listed applicant for CHLORIDE REAGENT?

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

What is the FDA product code for CHLORIDE REAGENT?

The FDA product code for CHLORIDE REAGENT is CHJ.

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Other records listing Pointe Scientific, Inc., as applicant

K070757MICROPROTEIN REAGENT SET K062118POINTE 360 K070251CARBON DIOXIDE LIQUID STABLE REAGENT K070207MULTI-ANALYTE CHEMISTRY CALIBRATOR K070504AMMONIA/ALCOHOL CONTROL SET K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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Related Devices (Code: CHJ)

K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.K943006CHLORIDE QVETPrisma Systems K934136OLYMPUS CHLORIDE REAGENT, MODIFICATIONOlympus Corp.K932528OLYMPUS CHLORID REAGENT, MODIFIEDOlympus Corp.K925338OLYMPUS CHLORIDE REAGENTOlympus 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.