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FDA 510(k)

PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

K-Number: K043167 · 2004-12-29

ApplicantPhamatech, Inc.
Decision Date2004-12-29
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K043167. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X?

PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Phamatech, Inc.. The 510(k) number is K043167.

When did PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X receive FDA 510(k) clearance?

PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X received FDA 510(k) clearance on 2004-12-29, under 510(k) number K043167.

Who is the listed applicant for PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X?

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

What is the FDA product code for PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X?

The FDA product code for PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X is JXM.

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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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