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FDA 510(k)

WELLCOLEX COLOUR SHIGELLA TEST ZC51

K-Number: K895461 · 1990-01-11

ApplicantWellcome Diagnostics
Decision Date1990-01-11
Product CodeGNB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLCOLEX COLOUR SHIGELLA TEST ZC51 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1990-01-11 under 510(k) number K895461. The device is classified under product code GNB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLCOLEX COLOUR SHIGELLA TEST ZC51?

WELLCOLEX COLOUR SHIGELLA TEST ZC51 is a medical device that received FDA 510(k) clearance on 1990-01-11. The listed applicant is Wellcome Diagnostics. The 510(k) number is K895461.

When did WELLCOLEX COLOUR SHIGELLA TEST ZC51 receive FDA 510(k) clearance?

WELLCOLEX COLOUR SHIGELLA TEST ZC51 received FDA 510(k) clearance on 1990-01-11, under 510(k) number K895461.

Who is the listed applicant for WELLCOLEX COLOUR SHIGELLA TEST ZC51?

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

What is the FDA product code for WELLCOLEX COLOUR SHIGELLA TEST ZC51?

The FDA product code for WELLCOLEX COLOUR SHIGELLA TEST ZC51 is GNB.

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Other records listing Wellcome Diagnostics 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.

K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01K864206REVEAL COLOUR STREP A ZL16

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Related Devices (Code: GNB)

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.

K961537SAS SHIGELLA SONNEI FORM II ANTISERUMSa Scientific, Inc.K961553SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUMSa Scientific, Inc.K961534SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)Sa Scientific, Inc.K961551SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUMSa Scientific, Inc.K961535SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUMSa Scientific, Inc.K961549SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUMSa Scientific, 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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