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FDA 510(k)

LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ

K-Number: K884731 · 1989-02-03

ApplicantAmdev, Inc.
Decision Date1989-02-03
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Amdev, Inc.. It received FDA 510(k) clearance on 1989-02-03 under 510(k) number K884731. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is a medical device that received FDA 510(k) clearance on 1989-02-03. The listed applicant is Amdev, Inc.. The 510(k) number is K884731.

When did LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ receive FDA 510(k) clearance?

LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ received FDA 510(k) clearance on 1989-02-03, under 510(k) number K884731.

Who is the listed applicant for LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

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

What is the FDA product code for LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

The FDA product code for LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is JFP.

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.

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Other records listing Amdev, 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.

K904726LYTENING TM 6/RK890524APEC GLUCOSE ANALYZERK880917LYTENING 5K863521LYTENING 2K853832LYTENING 1

Related Devices (Code: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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