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FDA 510(k)

BLOOD GAS/ISE LINEARITY CONTROL

K-Number: K920285 · 1992-07-14

ApplicantPhoenix Diagnostics, Inc.
Decision Date1992-07-14
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS/ISE LINEARITY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-07-14 under 510(k) number K920285. 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 BLOOD GAS/ISE LINEARITY CONTROL?

BLOOD GAS/ISE LINEARITY CONTROL is a medical device that received FDA 510(k) clearance on 1992-07-14. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K920285.

When did BLOOD GAS/ISE LINEARITY CONTROL receive FDA 510(k) clearance?

BLOOD GAS/ISE LINEARITY CONTROL received FDA 510(k) clearance on 1992-07-14, under 510(k) number K920285.

Who is the listed applicant for BLOOD GAS/ISE LINEARITY CONTROL?

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

What is the FDA product code for BLOOD GAS/ISE LINEARITY CONTROL?

The FDA product code for BLOOD GAS/ISE LINEARITY CONTROL is JJS.

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Other records listing Phoenix Diagnostics, 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.

K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMSK020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMSK020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsK020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULEK013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESK012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

View all 21 devices →

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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