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FDA 510(k)

ELECTROLYTE CONTROL

K-Number: K912513 · 1991-07-19

ApplicantVerichem Laboratories, Inc.
Decision Date1991-07-19
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECTROLYTE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K912513. 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 CONTROL?

ELECTROLYTE CONTROL is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K912513.

When did ELECTROLYTE CONTROL receive FDA 510(k) clearance?

ELECTROLYTE CONTROL received FDA 510(k) clearance on 1991-07-19, under 510(k) number K912513.

Who is the listed applicant for ELECTROLYTE CONTROL?

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

What is the FDA product code for ELECTROLYTE CONTROL?

The FDA product code for ELECTROLYTE CONTROL is JJR.

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Other records listing Verichem Laboratories, 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.

K112834MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLESK974290MICROPROTEIN STANDARD KITK973345MATRIX PLUS MULTI-CALIBRATOR KITK972333AMMONIA/IRON STANDARD KITK924904HDL-CHOLESTEROL STANDARD, MODIFICATIONK901113MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD

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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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