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FDA 510(k)

DYNEX BLOOD GAS QUALITY CONTROL SYS.

K-Number: K780144 · 1978-05-26

ApplicantAnalytical Products, Inc.
Decision Date1978-05-26
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNEX BLOOD GAS QUALITY CONTROL SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1978-05-26 under 510(k) number K780144. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNEX BLOOD GAS QUALITY CONTROL SYS.?

DYNEX BLOOD GAS QUALITY CONTROL SYS. is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is Analytical Products, Inc.. The 510(k) number is K780144.

When did DYNEX BLOOD GAS QUALITY CONTROL SYS. receive FDA 510(k) clearance?

DYNEX BLOOD GAS QUALITY CONTROL SYS. received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780144.

Who is the listed applicant for DYNEX BLOOD GAS QUALITY CONTROL SYS.?

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

What is the FDA product code for DYNEX BLOOD GAS QUALITY CONTROL SYS.?

The FDA product code for DYNEX BLOOD GAS QUALITY CONTROL SYS. is JJS.

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Other records listing Analytical Products, Inc. as applicant

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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