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FDA 510(k)

BLOOD GAS ANALYSIS, STANDARDS CONTROLS

K-Number: K813517 · 1981-12-31

ApplicantUnited Diagnostics, Inc.
Decision Date1981-12-31
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS ANALYSIS, STANDARDS CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813517. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GAS ANALYSIS, STANDARDS CONTROLS?

BLOOD GAS ANALYSIS, STANDARDS CONTROLS is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K813517.

When did BLOOD GAS ANALYSIS, STANDARDS CONTROLS receive FDA 510(k) clearance?

BLOOD GAS ANALYSIS, STANDARDS CONTROLS received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813517.

Who is the listed applicant for BLOOD GAS ANALYSIS, STANDARDS CONTROLS?

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

What is the FDA product code for BLOOD GAS ANALYSIS, STANDARDS CONTROLS?

The FDA product code for BLOOD GAS ANALYSIS, STANDARDS CONTROLS is CHL.

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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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