FDA 510(k)

MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12

K-Number: K004034 · 2001-03-08

Decision Date2001-03-08

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corp.. It received FDA 510(k) clearance on 2001-03-08 under 510(k) number K004034. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12?

MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 is a medical device that received FDA 510(k) clearance on 2001-03-08. The listed applicant is Branan Medical Corp.. The 510(k) number is K004034.

When did MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 receive FDA 510(k) clearance?

MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 received FDA 510(k) clearance on 2001-03-08, under 510(k) number K004034.

Who is the listed applicant for MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12?

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

What is the FDA product code for MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12?

The FDA product code for MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 is DKZ.

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Other records listing Branan Medical Corp. as applicant

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Related Devices (Code: DKZ)

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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.