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FDA 510(k)

REVEAL COLOUR STREP A ZL16

K-Number: K864206 · 1987-01-13

ApplicantWellcome Diagnostics
Decision Date1987-01-13
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REVEAL COLOUR STREP A ZL16 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864206. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REVEAL COLOUR STREP A ZL16?

REVEAL COLOUR STREP A ZL16 is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Wellcome Diagnostics. The 510(k) number is K864206.

When did REVEAL COLOUR STREP A ZL16 receive FDA 510(k) clearance?

REVEAL COLOUR STREP A ZL16 received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864206.

Who is the listed applicant for REVEAL COLOUR STREP A ZL16?

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 REVEAL COLOUR STREP A ZL16?

The FDA product code for REVEAL COLOUR STREP A ZL16 is GTZ.

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Other records listing Wellcome Diagnostics as applicant

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K915203D-DIMER WELLCOTEST (HA10)K910797STREPTEX ACID EXTRACTION KITK895461WELLCOLEX COLOUR SHIGELLA TEST ZC51K890146WELLCOLEX COLOUR SALMONELLA TEST ZL 50K875311WELLCOZYME HSV WZO2K861628WELLCOZYME ROTAVIRUS WZ01

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, 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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