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FDA 510(k)

LITHIUM DILUENT (1500 MM/E)

K-Number: K800039 · 1980-01-21

ApplicantGilford Diagnostics
Decision Date1980-01-21
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LITHIUM DILUENT (1500 MM/E) is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1980-01-21 under 510(k) number K800039. The device is classified under product code JIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITHIUM DILUENT (1500 MM/E)?

LITHIUM DILUENT (1500 MM/E) is a medical device that received FDA 510(k) clearance on 1980-01-21. The listed applicant is Gilford Diagnostics. The 510(k) number is K800039.

When did LITHIUM DILUENT (1500 MM/E) receive FDA 510(k) clearance?

LITHIUM DILUENT (1500 MM/E) received FDA 510(k) clearance on 1980-01-21, under 510(k) number K800039.

Who is the listed applicant for LITHIUM DILUENT (1500 MM/E)?

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

What is the FDA product code for LITHIUM DILUENT (1500 MM/E)?

The FDA product code for LITHIUM DILUENT (1500 MM/E) is JIH.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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Related Devices (Code: JIH)

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.

K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMAkers Biosciences, Inc.K031579INSTAREAD LITHIUM SYSTEMAkers Laboratories, Inc.K011033DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.K934106KODAK EKTACHEM DTSC II SLIDES (LI)Eastman Kodak CompanyK924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak CompanyK921403MODEL 654 ANALYZERCiba Corning Diagnostics 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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