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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Phoenix Diagnostics, Inc. — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

46 daysmedian FDA review time
93 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023268PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMSPhoenix Diagnostics, Inc.2002-11-15460
K020364PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMSPhoenix Diagnostics, Inc.2002-06-041200
K020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsPhoenix Diagnostics, Inc.2002-02-04190
K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MPhoenix Diagnostics, Inc.2002-02-01180
K013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIPhoenix Diagnostics, Inc.2001-12-18610
K012987PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTEPhoenix Diagnostics, Inc.2001-11-07620
K012509PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHPhoenix Diagnostics, Inc.2001-10-09640
K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.1996-05-13910
K945860SPECTRUM CO-OXIMETER LINEARITY CONTROLPhoenix Diagnostics, Inc.1995-01-17470
K920285BLOOD GAS/ISE LINEARITY CONTROLPhoenix Diagnostics, Inc.1992-07-141740
K912718ENZYME LINEARITY CONTROLPhoenix Diagnostics, Inc.1991-09-06800
K904075CLINICAL CHEMISTRY CONTROLPhoenix Diagnostics, Inc.1990-12-06930
K902675MULTI ANALYTE MIXTURE, CALIBRATORSPhoenix Diagnostics, Inc.1990-07-31420
K902616BILIRUBIN CONTROLPhoenix Diagnostics, Inc.1990-07-19360
K902094BLOOD GAS/ISE CONTROLSPhoenix Diagnostics, Inc.1990-07-19720
K902095BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLSPhoenix Diagnostics, Inc.1990-06-12350
K902267BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTSPhoenix Diagnostics, Inc.1990-06-12220
K902266ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)Phoenix Diagnostics, Inc.1990-06-06160
K901985BLOOD GAS CONTROLSPhoenix Diagnostics, Inc.1990-06-06350
K901976BLOOD GAS/CO-OXIMETRY CONTROLPhoenix Diagnostics, Inc.1990-05-31290
K901986CO-OXIMETER CONTROLSPhoenix Diagnostics, Inc.1990-05-31290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda