Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BLOOD GAS CONTROLS

K-Number: K901985 · 1990-06-06

ApplicantPhoenix Diagnostics, Inc.
Decision Date1990-06-06
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS CONTROLS 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 1990-06-06 under 510(k) number K901985. 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 CONTROLS?

BLOOD GAS CONTROLS is a medical device that received FDA 510(k) clearance on 1990-06-06. The listed applicant is Phoenix Diagnostics, Inc.. The 510(k) number is K901985.

When did BLOOD GAS CONTROLS receive FDA 510(k) clearance?

BLOOD GAS CONTROLS received FDA 510(k) clearance on 1990-06-06, under 510(k) number K901985.

Who is the listed applicant for BLOOD GAS CONTROLS?

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 CONTROLS?

The FDA product code for BLOOD GAS CONTROLS is JJS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑