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FDA 510(k)

BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

K-Number: K801795 · 1980-09-16

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-09-16
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. 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 1980-09-16 under 510(k) number K801795. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.?

BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801795.

When did BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. receive FDA 510(k) clearance?

BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801795.

Who is the listed applicant for BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.?

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 BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.?

The FDA product code for BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. is JGS.

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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 KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801662J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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Related Devices (Code: JGS)

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.

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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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