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FDA 510(k)

CHLORIDE ASSAY KIT

K-Number: K852058 · 1985-07-12

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1985-07-12
Product CodeCHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHLORIDE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K852058. 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 ASSAY KIT?

CHLORIDE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K852058.

When did CHLORIDE ASSAY KIT receive FDA 510(k) clearance?

CHLORIDE ASSAY KIT received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852058.

Who is the listed applicant for CHLORIDE ASSAY KIT?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLORIDE ASSAY KIT?

The FDA product code for CHLORIDE ASSAY KIT is CHJ.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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Related Devices (Code: CHJ)

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.

K010670PICCOLO CHLORIDE TEST SYSTEMAbaxis, Inc.K945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERCatachem, Inc.K943006CHLORIDE QVETPrisma SystemsK934136OLYMPUS 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.

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