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FDA 510(k)

VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT

K-Number: K890840 · 1989-03-27

ApplicantAdi Diagnostics, Inc.
Decision Date1989-03-27
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Adi Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-03-27 under 510(k) number K890840. 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 VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT?

VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT is a medical device that received FDA 510(k) clearance on 1989-03-27. The listed applicant is Adi Diagnostics, Inc.. The 510(k) number is K890840.

When did VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT receive FDA 510(k) clearance?

VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT received FDA 510(k) clearance on 1989-03-27, under 510(k) number K890840.

Who is the listed applicant for VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT?

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

What is the FDA product code for VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT?

The FDA product code for VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT is GTZ.

Related Clinical Trials

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Other records listing Adi Diagnostics, 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.

K910487VISUWELL SYPHILIS ANTIGENK900973VISUWELL(R) CHLAMYDIAK900338VISUWELL(R) REAGIN TEST (MODIFICATION)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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