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510(k) K973142

DBEST REAGENT STRIP FOR URINALYSIS by Ameritek, Inc. — Product Code JIL

K973142 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST REAGENT STRIP FOR URINALYSIS". The FDA issued a decision of Substantially Equivalent on October 20, 1997. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
August 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Ameritek, Inc.

  • K001215 — DBEST HCG 2 IU/ML TEST KIT (June 22, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K974508 — DBEST ONE-STEP OVULATION TEST (February 2, 1998)

Other clearances for product code JIL

  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K183432 — cobas u 601 urinalysis test system (May 7, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)
  • K180356 — inui In-Home Urine Analysis Test System (May 25, 2018)
  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)

FDA data resources