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FDA 510(k)

ALKALINE PHOSPHOTASE REAGENT SET

K-Number: K821200 · 1982-07-13

ApplicantOmega Medical Electronics
Decision Date1982-07-13
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHOTASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821200. The device is classified under product code CIO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHOTASE REAGENT SET?

ALKALINE PHOSPHOTASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Omega Medical Electronics. The 510(k) number is K821200.

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

ALKALINE PHOSPHOTASE REAGENT SET received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821200.

Who is the listed applicant for ALKALINE PHOSPHOTASE REAGENT SET?

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

What is the FDA product code for ALKALINE PHOSPHOTASE REAGENT SET?

The FDA product code for ALKALINE PHOSPHOTASE REAGENT SET is CIO.

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Other records listing Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

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Related Devices (Code: CIO)

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.

K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.K860351ALKALINE PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.K855192ALKALINE PHOSPHATASE REAGENT SETTechnostics Intl.K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, 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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