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FDA 510(k)

MULTI-FUNCTION BLOOD GAS CONTROL

K-Number: K874408 · 1987-12-14

ApplicantBionostics, Inc.
Decision Date1987-12-14
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTI-FUNCTION BLOOD GAS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1987-12-14 under 510(k) number K874408. 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 MULTI-FUNCTION BLOOD GAS CONTROL?

MULTI-FUNCTION BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1987-12-14. The listed applicant is Bionostics, Inc.. The 510(k) number is K874408.

When did MULTI-FUNCTION BLOOD GAS CONTROL receive FDA 510(k) clearance?

MULTI-FUNCTION BLOOD GAS CONTROL received FDA 510(k) clearance on 1987-12-14, under 510(k) number K874408.

Who is the listed applicant for MULTI-FUNCTION BLOOD GAS CONTROL?

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

What is the FDA product code for MULTI-FUNCTION BLOOD GAS CONTROL?

The FDA product code for MULTI-FUNCTION BLOOD GAS CONTROL is JJS.

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Other records listing Bionostics, 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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