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FDA 510(k)

ULTRACHEM INORGANIC PHOSPHORUS

K-Number: K770820 · 1977-07-11

ApplicantHarleco
Decision Date1977-07-11
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM INORGANIC PHOSPHORUS is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K770820. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM INORGANIC PHOSPHORUS?

ULTRACHEM INORGANIC PHOSPHORUS is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Harleco. The 510(k) number is K770820.

When did ULTRACHEM INORGANIC PHOSPHORUS receive FDA 510(k) clearance?

ULTRACHEM INORGANIC PHOSPHORUS received FDA 510(k) clearance on 1977-07-11, under 510(k) number K770820.

Who is the listed applicant for ULTRACHEM INORGANIC PHOSPHORUS?

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

What is the FDA product code for ULTRACHEM INORGANIC PHOSPHORUS?

The FDA product code for ULTRACHEM INORGANIC PHOSPHORUS is CEO.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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Related Devices (Code: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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