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FDA 510(k)

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY

K-Number: K935554 · 1995-08-30

ApplicantSyntron Bioresearch, Inc.
Decision Date1995-08-30
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syntron Bioresearch, Inc.. It received FDA 510(k) clearance on 1995-08-30 under 510(k) number K935554. 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 QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY?

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY is a medical device that received FDA 510(k) clearance on 1995-08-30. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K935554.

When did QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY receive FDA 510(k) clearance?

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY received FDA 510(k) clearance on 1995-08-30, under 510(k) number K935554.

Who is the listed applicant for QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY?

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

What is the FDA product code for QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY?

The FDA product code for QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY is GTZ.

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Other records listing Syntron Bioresearch, Inc. as applicant

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K993490QUICKSTRIP ONE STEP OPIATES TESTK993491QUICKPAC II ONE STEP OPIATES TESTK992990QUICKPAC II ONE STEP COCAINE TESTK992748DRUGCHECK X MULTIDRUG SCREENING DEVICEK992207QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMK990325QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE

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Related Devices (Code: GTZ)

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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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