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FDA 510(k)

EZ DETECT, 5 MINUTE STREP-A COLOR TEST

K-Number: K860923 · 1986-05-16

ApplicantSelf Care Systems, Inc.
Decision Date1986-05-16
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EZ DETECT, 5 MINUTE STREP-A COLOR TEST is the device name listed in this FDA 510(k) record. The listed applicant is Self Care Systems, Inc.. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K860923. 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 EZ DETECT, 5 MINUTE STREP-A COLOR TEST?

EZ DETECT, 5 MINUTE STREP-A COLOR TEST is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Self Care Systems, Inc.. The 510(k) number is K860923.

When did EZ DETECT, 5 MINUTE STREP-A COLOR TEST receive FDA 510(k) clearance?

EZ DETECT, 5 MINUTE STREP-A COLOR TEST received FDA 510(k) clearance on 1986-05-16, under 510(k) number K860923.

Who is the listed applicant for EZ DETECT, 5 MINUTE STREP-A COLOR TEST?

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

What is the FDA product code for EZ DETECT, 5 MINUTE STREP-A COLOR TEST?

The FDA product code for EZ DETECT, 5 MINUTE STREP-A COLOR TEST is GTZ.

Related Clinical Trials

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.

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Other records listing Self Care Systems, 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.

K854358EZ DETECH-URINE BLOOD TEST STICKSK860028MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL

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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