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510(k) K954977

URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) by Teco Diagnostics — Product Code JRE

K954977 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on March 11, 1996. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1996
Date Received
October 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer For Clinical Use
Device Class
Class I
Regulation Number
862.2800
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 JRE

  • K941903 — MODEL 2740 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941901 — MODEL 2721 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941906 — MODEL 2730 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941902 — MODEL 3471 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941905 — MODEL 3461 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941904 — MODEL A300CL CLINICAL REFRACTOMETER (December 13, 1994)
  • K891681 — DILECTRON URINARY CONDUCTIVITY PROBE (May 1, 1990)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K831213 — SPECIFIC GRAVITY INSTRUMENT (June 30, 1983)
  • K811342 — REAGENT STRIPS FOR URINALYSIS (September 1, 1981)

FDA data resources