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FDA 510(k)

QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)

K-Number: K961354 · 1996-06-14

ApplicantRadiometer America, Inc.
Decision Date1996-06-14
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1996-06-14 under 510(k) number K961354. 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 QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) is a medical device that received FDA 510(k) clearance on 1996-06-14. The listed applicant is Radiometer America, Inc.. The 510(k) number is K961354.

When did QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) receive FDA 510(k) clearance?

QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) received FDA 510(k) clearance on 1996-06-14, under 510(k) number K961354.

Who is the listed applicant for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

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

What is the FDA product code for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

The FDA product code for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) is JJS.

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Other records listing Radiometer America, Inc. 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.

K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitK992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULEK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

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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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