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FDA 510(k)

QUICKSTRIP ONE STEP OPIATES TEST

K-Number: K993490 · 1999-10-29

ApplicantSyntron Bioresearch, Inc.
Decision Date1999-10-29
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKSTRIP ONE STEP OPIATES TEST 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 1999-10-29 under 510(k) number K993490. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKSTRIP ONE STEP OPIATES TEST?

QUICKSTRIP ONE STEP OPIATES TEST is a medical device that received FDA 510(k) clearance on 1999-10-29. The listed applicant is Syntron Bioresearch, Inc.. The 510(k) number is K993490.

When did QUICKSTRIP ONE STEP OPIATES TEST receive FDA 510(k) clearance?

QUICKSTRIP ONE STEP OPIATES TEST received FDA 510(k) clearance on 1999-10-29, under 510(k) number K993490.

Who is the listed applicant for QUICKSTRIP ONE STEP OPIATES TEST?

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 QUICKSTRIP ONE STEP OPIATES TEST?

The FDA product code for QUICKSTRIP ONE STEP OPIATES TEST is DJG.

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Other records listing Syntron Bioresearch, 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.

K993491QUICKPAC 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 DEVICEK983113BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

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Related Devices (Code: DJG)

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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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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