ONE STEP LH TEST— 510(k) K935134

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K935134 for ONE STEP LH TEST, Substantially Equivalent on 1994-01-11. Applicant: Tcpi, Inc.. Device class: 1.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1993-10-28
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tcpi, Inc.

K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST1998-12-22
K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE1998-10-07
K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST1998-06-16
K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST1998-04-29
K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)1996-08-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.