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FDA 510(k)

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

K-Number: K823578 · 1983-01-07

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-01-07
Product CodeCIO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823578. 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 COBAS STANDARDS FOR CALCIUM-IN-ORGANIC?

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K823578.

When did COBAS STANDARDS FOR CALCIUM-IN-ORGANIC receive FDA 510(k) clearance?

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823578.

Who is the listed applicant for COBAS STANDARDS FOR CALCIUM-IN-ORGANIC?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS STANDARDS FOR CALCIUM-IN-ORGANIC?

The FDA product code for COBAS STANDARDS FOR CALCIUM-IN-ORGANIC is CIO.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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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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