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FDA 510(k)

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)

K-Number: K972619 · 1997-08-20

ApplicantPhamatech
Decision Date1997-08-20
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K972619. 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 QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)?

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Phamatech. The 510(k) number is K972619.

When did QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) receive FDA 510(k) clearance?

QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) received FDA 510(k) clearance on 1997-08-20, under 510(k) number K972619.

Who is the listed applicant for QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)?

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

What is the FDA product code for QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)?

The FDA product code for QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) is DJG.

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Other records listing Phamatech 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.

K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010653AT HOME DRUG TEST, MODEL 9068 T

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Related Devices (Code: DJG)

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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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