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FDA 510(k)

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)

K-Number: K971591 · 1998-03-13

ApplicantDavid C. Bishop, Ph.D.
Decision Date1998-03-13
Product CodeLSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) is the device name listed in this FDA 510(k) record. The listed applicant is David C. Bishop, Ph.D.. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K971591. The device is classified under product code LSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)?

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is David C. Bishop, Ph.D.. The 510(k) number is K971591.

When did INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) receive FDA 510(k) clearance?

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) received FDA 510(k) clearance on 1998-03-13, under 510(k) number K971591.

Who is the listed applicant for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)?

The FDA 510(k) record lists David C. Bishop, Ph.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)?

The FDA product code for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) is LSQ.

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Related Devices (Code: LSQ)

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.

K920569INDXTM DIP-S-TICKSTMIntercare Diagnostics, Inc.K901597INDX DIP S TICKSIntercare Diagnostics, Inc.K872129LATEX R. CONORIIHealth Research, Inc.

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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