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FDA 510(k)

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)

K-Number: K971007 · 1998-06-01

ApplicantMrl Diagnostics
Decision Date1998-06-01
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) is the device name listed in this FDA 510(k) record. The listed applicant is Mrl Diagnostics. It received FDA 510(k) clearance on 1998-06-01 under 510(k) number K971007. 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 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)?

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) is a medical device that received FDA 510(k) clearance on 1998-06-01. The listed applicant is Mrl Diagnostics. The 510(k) number is K971007.

When did LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) receive FDA 510(k) clearance?

LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) received FDA 510(k) clearance on 1998-06-01, under 510(k) number K971007.

Who is the listed applicant for LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)?

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

What is the FDA product code for LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)?

The FDA product code for LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M) is LSR.

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Other records listing Mrl Diagnostics as applicant

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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.

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