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FDA 510(k)

WELLCOLEX COLOUR SALMONELLA TEST ZL 50

K-Number: K890146 · 1989-02-16

ApplicantWellcome Diagnostics
Decision Date1989-02-16
Product CodeGRM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLCOLEX COLOUR SALMONELLA TEST ZL 50 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1989-02-16 under 510(k) number K890146. The device is classified under product code GRM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLCOLEX COLOUR SALMONELLA TEST ZL 50?

WELLCOLEX COLOUR SALMONELLA TEST ZL 50 is a medical device that received FDA 510(k) clearance on 1989-02-16. The listed applicant is Wellcome Diagnostics. The 510(k) number is K890146.

When did WELLCOLEX COLOUR SALMONELLA TEST ZL 50 receive FDA 510(k) clearance?

WELLCOLEX COLOUR SALMONELLA TEST ZL 50 received FDA 510(k) clearance on 1989-02-16, under 510(k) number K890146.

Who is the listed applicant for WELLCOLEX COLOUR SALMONELLA TEST ZL 50?

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 SALMONELLA TEST ZL 50?

The FDA product code for WELLCOLEX COLOUR SALMONELLA TEST ZL 50 is GRM.

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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 KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01K864206REVEAL COLOUR STREP A ZL16

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Related Devices (Code: GRM)

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.

K961957SAS SALMONELLA H Z4, Z32 ANTISERUMSa Scientific, Inc.K961953SAS SALMONELA H Z24 ANTISERUMSa Scientific, Inc.K961952SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMSSa Scientific, Inc.K961955SAS SALMONELLA H Z42 ANTISERUMSa Scientific, Inc.K961966SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUMSa Scientific, Inc.K961961SAS SALMONELLA H F,G,T 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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