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FDA 510(k)

STAT-TRAK LIQUID ELECTROLYTE CONTROL

K-Number: K831389 · 1983-08-10

ApplicantUnited Diagnostics, Inc.
Decision Date1983-08-10
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT-TRAK LIQUID ELECTROLYTE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-08-10 under 510(k) number K831389. 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 STAT-TRAK LIQUID ELECTROLYTE CONTROL?

STAT-TRAK LIQUID ELECTROLYTE CONTROL is a medical device that received FDA 510(k) clearance on 1983-08-10. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K831389.

When did STAT-TRAK LIQUID ELECTROLYTE CONTROL receive FDA 510(k) clearance?

STAT-TRAK LIQUID ELECTROLYTE CONTROL received FDA 510(k) clearance on 1983-08-10, under 510(k) number K831389.

Who is the listed applicant for STAT-TRAK LIQUID ELECTROLYTE CONTROL?

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

What is the FDA product code for STAT-TRAK LIQUID ELECTROLYTE CONTROL?

The FDA product code for STAT-TRAK LIQUID ELECTROLYTE CONTROL is JJR.

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Other records listing United 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.

K884977GAS TRAK PLUSK862278GAS-TRAKK843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3K844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3K831814CALIBRATION STANDARD-HEMOGLOBINK831813CO-OXIMETER CONTROL

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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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