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510(k) K931227

USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 by U.S. Drug Testing, Inc. — Product Code KZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1993
Date Received
March 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography (Liquid, Gel), Clinical Use
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type

Other clearances by U.S. Drug Testing, Inc.

  • K940912 — USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (June 2, 1994)
  • K935629 — USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 (April 12, 1994)
  • K934693 — AMPHETAMINE TEST SYSTEM (November 22, 1993)
  • K932318 — USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 (June 15, 1993)
  • K930985 — USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 (April 27, 1993)

Other clearances for product code KZR

  • K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (October 6, 1997)
  • K905538 — COLUMNS LIQUID CHROMATOGRAPHY DPM (January 25, 1991)
  • K861392 — SYVA SOLID PHASE COLUMNS SYSTEM II (June 13, 1986)
  • K860197 — SERIES 410 LC PUMP (March 17, 1986)
  • K851945 — VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM (May 24, 1985)
  • K843568 — LIQUID CHROMATOGRAPH 400 (November 20, 1984)
  • K841890 — VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY (June 14, 1984)
  • K840977 — LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (April 19, 1984)
  • K832201 — CHROM-PREP (August 16, 1983)
  • K802725 — VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (December 11, 1980)