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510(k) K941765

HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE by Tcpi, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
March 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Tcpi, Inc.

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  • K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (June 16, 1998)
  • K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (April 29, 1998)
  • K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (August 20, 1996)
  • K954968 — HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (July 26, 1996)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (March 19, 1996)
  • K952096 — ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (August 17, 1995)
  • K951892 — ONE STEP URINE DRUG OF ABUSE COCAINE TEST (August 17, 1995)

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