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FDA 510(k)

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000

K-Number: K931227 · 1993-05-06

ApplicantU.S. Drug Testing, Inc.
Decision Date1993-05-06
Product CodeKZR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Drug Testing, Inc.. It received FDA 510(k) clearance on 1993-05-06 under 510(k) number K931227. The device is classified under product code KZR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000?

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 is a medical device that received FDA 510(k) clearance on 1993-05-06. The listed applicant is U.S. Drug Testing, Inc.. The 510(k) number is K931227.

When did USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 receive FDA 510(k) clearance?

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 received FDA 510(k) clearance on 1993-05-06, under 510(k) number K931227.

Who is the listed applicant for USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000?

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

What is the FDA product code for USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000?

The FDA product code for USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 is KZR.

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Other records listing U.S. Drug Testing, 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.

K940912USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500K935629USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400K934693AMPHETAMINE TEST SYSTEMK932318USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200K930985USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

Related Devices (Code: KZR)

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.

K9730742487 DUAL WAVELENGTH ABSORBANCE DETECTORWaters CorporationK905538COLUMNS LIQUID CHROMATOGRAPHY DPMMillpore Corp.K861392SYVA SOLID PHASE COLUMNS SYSTEM IISyva Co.K860197SERIES 410 LC PUMPThe Perkin-Elmer Corp.K851945VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEMVarian Assoc., Inc.K843568LIQUID CHROMATOGRAPH 400The Perkin-Elmer Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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