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FDA 510(k)

SODIUM REAGENT SET

K-Number: K914039 · 1991-10-31

ApplicantSterling Diagnostics, Inc.
Decision Date1991-10-31
Product CodeCEI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K914039. The device is classified under product code CEI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM REAGENT SET?

SODIUM REAGENT SET is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K914039.

When did SODIUM REAGENT SET receive FDA 510(k) clearance?

SODIUM REAGENT SET received FDA 510(k) clearance on 1991-10-31, under 510(k) number K914039.

Who is the listed applicant for SODIUM REAGENT SET?

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

What is the FDA product code for SODIUM REAGENT SET?

The FDA product code for SODIUM REAGENT SET is CEI.

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Other records listing Sterling Diagnostics, Inc. 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SETK862210UREA NITROGEN (GLDH) REAGENT SET (UV)

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Related Devices (Code: CEI)

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.

K043268SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2Randox Laboratories, Ltd.K902572SODIUM REAGENT SETTech Intl. Co.K832552SODIUM TEST KITMallinckrodt Critical Care

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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