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FDA 510(k)

PROTEIN-BASED BLOOD GAS CONTROL

K-Number: K812541 · 1981-09-23

ApplicantAmerican Dade
Decision Date1981-09-23
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTEIN-BASED BLOOD GAS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812541. 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 PROTEIN-BASED BLOOD GAS CONTROL?

PROTEIN-BASED BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is American Dade. The 510(k) number is K812541.

When did PROTEIN-BASED BLOOD GAS CONTROL receive FDA 510(k) clearance?

PROTEIN-BASED BLOOD GAS CONTROL received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812541.

Who is the listed applicant for PROTEIN-BASED BLOOD GAS CONTROL?

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 PROTEIN-BASED BLOOD GAS CONTROL?

The FDA product code for PROTEIN-BASED BLOOD GAS CONTROL 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 ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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