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FDA 510(k)

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

K-Number: K872196 · 1987-07-31

ApplicantAmerican Dade
Decision Date1987-07-31
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872196. 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 AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III?

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is American Dade. The 510(k) number is K872196.

When did AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III receive FDA 510(k) clearance?

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872196.

Who is the listed applicant for AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III?

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

What is the FDA product code for AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III?

The FDA product code for AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III is JJS.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK871972STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

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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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