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FDA 510(k)

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024

K-Number: K991063 · 1999-09-21

ApplicantImmunetics, Inc.
Decision Date1999-09-21
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 is the device name listed in this FDA 510(k) record. The listed applicant is Immunetics, Inc.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K991063. 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 QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024?

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Immunetics, Inc.. The 510(k) number is K991063.

When did QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 receive FDA 510(k) clearance?

QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 received FDA 510(k) clearance on 1999-09-21, under 510(k) number K991063.

Who is the listed applicant for QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024?

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

What is the FDA product code for QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024?

The FDA product code for QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 is LSR.

Related Clinical Trials

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Other records listing Immunetics, 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.

K040407QUICKELISA ANTHRAX-PA KITK003754IMMUNETICS C6 LYME ELISA KITK991062QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

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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