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FDA 510(k)

TDX(R) LITES(TM) LITHIUM

K-Number: K894328 · 1989-11-13

ApplicantAbbott Laboratories
Decision Date1989-11-13
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDX(R) LITES(TM) LITHIUM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K894328. 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 TDX(R) LITES(TM) LITHIUM?

TDX(R) LITES(TM) LITHIUM is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Abbott Laboratories. The 510(k) number is K894328.

When did TDX(R) LITES(TM) LITHIUM receive FDA 510(k) clearance?

TDX(R) LITES(TM) LITHIUM received FDA 510(k) clearance on 1989-11-13, under 510(k) number K894328.

Who is the listed applicant for TDX(R) LITES(TM) LITHIUM?

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

What is the FDA product code for TDX(R) LITES(TM) LITHIUM?

The FDA product code for TDX(R) LITES(TM) LITHIUM 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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