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FDA 510(k)

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.

K-Number: K890335 · 1989-02-17

ApplicantAlpkem Corp.
Decision Date1989-02-17
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890335. The device is classified under product code CGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.?

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Alpkem Corp.. The 510(k) number is K890335.

When did SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. receive FDA 510(k) clearance?

SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890335.

Who is the listed applicant for SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.?

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

What is the FDA product code for SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.?

The FDA product code for SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. is CGE.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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Related Devices (Code: CGE)

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.

K855185GLUCOSE REAGENT SETTechnostics Intl.K850930GLUCOSEDilab, Inc.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.K8100896% ORTHO LOLIUDINE REAGENT IN GLACID ACIAnco Medical Reagents & Assoc.

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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