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510(k) K970120

BILE ACIDS REAGENT SET by Teco Diagnostics — Product Code KWW

K970120 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "BILE ACIDS REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 24, 1997. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1997
Date Received
January 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cholyglycine, Bile Acids
Device Class
Class II
Regulation Number
862.1177
Review Panel
CH
Submission Type

Other clearances by Teco Diagnostics

  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (February 4, 2011)

Other clearances for product code KWW

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042A (December 7, 2005)
  • K872296 — BILE ACIDS REAGENT (August 26, 1987)
  • K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (January 16, 1981)
  • K781337 — CONJUGATED BILE ACIDS RIA KIT (August 11, 1978)

FDA data resources