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FDA 510(k)

INSTAREAD LITHIUM SYSTEM

K-Number: K031579 · 2003-12-19

ApplicantAkers Laboratories, Inc.
Decision Date2003-12-19
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INSTAREAD LITHIUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Akers Laboratories, Inc.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K031579. 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 INSTAREAD LITHIUM SYSTEM?

INSTAREAD LITHIUM SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Akers Laboratories, Inc.. The 510(k) number is K031579.

When did INSTAREAD LITHIUM SYSTEM receive FDA 510(k) clearance?

INSTAREAD LITHIUM SYSTEM received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031579.

Who is the listed applicant for INSTAREAD LITHIUM SYSTEM?

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

What is the FDA product code for INSTAREAD LITHIUM SYSTEM?

The FDA product code for INSTAREAD LITHIUM SYSTEM is JIH.

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 Akers 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.

K040293HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAYK030815AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

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.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.K895465AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZEBaxter Healthcare 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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