Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)

K-Number: K971169 · 1998-02-17

ApplicantCambridge Biotech Corp.
Decision Date1998-02-17
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Biotech Corp.. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K971169. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)?

CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Cambridge Biotech Corp.. The 510(k) number is K971169.

When did CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) receive FDA 510(k) clearance?

CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) received FDA 510(k) clearance on 1998-02-17, under 510(k) number K971169.

Who is the listed applicant for CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)?

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

What is the FDA product code for CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)?

The FDA product code for CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111) is LSR.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cambridge Biotech Corp. 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.

K971170CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)K911958CYTOCLONE A & B EIA

Related Devices (Code: LSR)

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.

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificK220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG

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.

↑