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FDA 510(k)

REAGENT, CHLORIDE, COULTER

K-Number: K770752 · 1977-06-17

ApplicantCoulter Electronics, Inc.
Decision Date1977-06-17
Product CodeCHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, CHLORIDE, COULTER is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770752. 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 REAGENT, CHLORIDE, COULTER?

REAGENT, CHLORIDE, COULTER is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K770752.

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

REAGENT, CHLORIDE, COULTER received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770752.

Who is the listed applicant for REAGENT, CHLORIDE, COULTER?

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

What is the FDA product code for REAGENT, CHLORIDE, COULTER?

The FDA product code for REAGENT, CHLORIDE, COULTER is CHJ.

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Other records listing Coulter Electronics, Inc. as applicant

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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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