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FDA 510(k)

CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)

K-Number: K971170 · 1998-02-17

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

Device Summary

CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) 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 K971170. 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 IGM WESTERN BLOT (90112)?

CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) 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 K971170.

When did CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) receive FDA 510(k) clearance?

CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) received FDA 510(k) clearance on 1998-02-17, under 510(k) number K971170.

Who is the listed applicant for CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)?

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 IGM WESTERN BLOT (90112)?

The FDA product code for CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) 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.

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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.

K971169CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)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.

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Official Source

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