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FDA 510(k)

AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE

K-Number: K895465 · 1989-12-27

ApplicantBaxter Healthcare Corp
Decision Date1989-12-27
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K895465. The device is classified under product code JIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE?

AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K895465.

When did AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE receive FDA 510(k) clearance?

AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE received FDA 510(k) clearance on 1989-12-27, under 510(k) number K895465.

Who is the listed applicant for AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE?

The FDA product code for AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE is JIH.

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Related Devices (Code: JIH)

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.

K050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEMAkers Biosciences, Inc.K031579INSTAREAD LITHIUM SYSTEMAkers Laboratories, Inc.K011033DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.K934106KODAK EKTACHEM DTSC II SLIDES (LI)Eastman Kodak CompanyK924488KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)Eastman Kodak CompanyK921403MODEL 654 ANALYZERCiba Corning Diagnostics 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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