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FDA 510(k)

REAGENT KIT, BAKERS DIAGNOSTIC

K-Number: K790044 · 1979-02-22

ApplicantJ.T. Baker Chemical Co.
Decision Date1979-02-22
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT KIT, BAKERS DIAGNOSTIC is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1979-02-22 under 510(k) number K790044. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT KIT, BAKERS DIAGNOSTIC?

REAGENT KIT, BAKERS DIAGNOSTIC is a medical device that received FDA 510(k) clearance on 1979-02-22. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K790044.

When did REAGENT KIT, BAKERS DIAGNOSTIC receive FDA 510(k) clearance?

REAGENT KIT, BAKERS DIAGNOSTIC received FDA 510(k) clearance on 1979-02-22, under 510(k) number K790044.

Who is the listed applicant for REAGENT KIT, BAKERS DIAGNOSTIC?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT KIT, BAKERS DIAGNOSTIC?

The FDA product code for REAGENT KIT, BAKERS DIAGNOSTIC is CGX.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

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Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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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