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FDA 510(k)

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

K-Number: K050338 · 2005-03-04

ApplicantAkers Biosciences, Inc.
Decision Date2005-03-04
Product CodeJIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Akers Biosciences, Inc.. It received FDA 510(k) clearance on 2005-03-04 under 510(k) number K050338. 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 MODIFICATION TO: INSTAREAD LITHIUM SYSTEM?

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-04. The listed applicant is Akers Biosciences, Inc.. The 510(k) number is K050338.

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

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM received FDA 510(k) clearance on 2005-03-04, under 510(k) number K050338.

Who is the listed applicant for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM?

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

What is the FDA product code for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM?

The FDA product code for MODIFICATION TO: INSTAREAD LITHIUM SYSTEM is JIH.

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Other records listing Akers Biosciences, 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.

K102338BREATHSCN PROK062971BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMSK060761BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORSK052697HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

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.

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.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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