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FDA 510(k)

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)

K-Number: K902266 · 1990-06-06

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

Device Summary

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) 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 K902266. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)?

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) 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 K902266.

When did ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) receive FDA 510(k) clearance?

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) received FDA 510(k) clearance on 1990-06-06, under 510(k) number K902266.

Who is the listed applicant for ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)?

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 ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)?

The FDA product code for ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) is JJR.

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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: JJR)

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.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K955630RNA MEDICAL HEMAT CONTROLBionostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat Corp.

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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