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510(k) K994093

AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C by Phamatech — Product Code LCL

K994093 is an FDA 510(k) premarket notification submitted by Phamatech for the device "AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C". The FDA issued a decision of Substantially Equivalent on December 16, 1999. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Phamatech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1999
Date Received
December 3, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Phamatech

  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K131069 — QUICKSCREEN AMPHETINE 500 TEST (May 14, 2014)
  • K103295 — QUICKSCREEN COCAINE 150 SCREENING TEST (February 1, 2012)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113 (February 25, 2005)
  • K043051 — QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (February 7, 2005)
  • K043167 — PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND (December 29, 2004)
  • K041578 — QUICKSCREEN, MODELS 9177X AND 9178X (September 10, 2004)
  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 2004)

Other clearances for product code LCL

  • K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (February 11, 2002)
  • K913864 — PCP DIRECT RIA KIT (I-125) (October 11, 1991)
  • K890882 — ABUSCREEN FP FOR PHENCYCLIDINE (March 15, 1989)
  • K882179 — EMIT HVA PHENCYCLIDINE ASSAY (July 12, 1988)
  • K880011 — REVISED LABELING FOR ADX PHENCYCLIDINE (February 11, 1988)
  • K874626 — REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (January 11, 1988)
  • K874484 — REVISED LABELING FOR TDX PHENCYCLIDINE (November 23, 1987)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K800514 — PHENCYCLIDINE DIRECT BLOOD RIA KIT (March 19, 1980)
  • K790655 — ABUSCREEN RIA FOR PHENCYCLIDINE (June 15, 1979)

FDA data resources