Cambridge Biotech Human Lyme Igg Western Blot (90111)

FDA 510(k) K971169 · Cambridge Biotech Corp.

Substantially Equivalent

510(k) numberK971169

Submission

Device name
Cambridge Biotech Human Lyme Igg Western Blot (90111)
Applicant
Cambridge Biotech Corp.
Rockville, MD, US
Received
March 28, 1997
Decision date
February 17, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LSR – Reagent, Borrelia Serological Reagent
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3830
Specialty
Microbiology

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K242872iDart Lyme IgM ImmunoBlot KitLSR · Traditional Id-Fish Technology, Inc.06/12/2025SE
K233367iDart Lyme IgG ImmunoBlot KitLSR · Traditional Id-Fish Technology, Inc.08/12/2024SE
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K220016Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional Viramed Biotech AG08/19/2022SE
K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional Gold Standard Diagnostics03/22/2021SE
K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional Gold Standard Diagnostics03/22/2021SE
K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional Gold Standard Diagnostics03/22/2021SE
K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional Gold Standard Diagnostics03/22/2021SE

More from Gold Standard Diagnostics

510(k)DeviceDecision
K971170Cambridge Biotech Human Lyme Igm Western Blot (90112)LSR · Traditional 02/17/1998SE
K911958Cytoclone a & B EiaLLH · Traditional 07/30/1991SE

Questions and answers

When was Cambridge Biotech Human Lyme Igg Western Blot (90111) cleared by the FDA?

Cambridge Biotech Human Lyme Igg Western Blot (90111) (K971169) received a 510(k) decision of Substantially Equivalent on February 17, 1998, 326 days after the submission was received.

What is the product code of K971169?

The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.