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510(k) K842168

ATAGO URINE SPECIFIC GRAVITY & SERUM by Kyoto Diagnostics, Inc. — Product Code JRE

K842168 is an FDA 510(k) premarket notification submitted by Kyoto Diagnostics, Inc. for the device "ATAGO URINE SPECIFIC GRAVITY & SERUM". The FDA issued a decision of Substantially Equivalent on July 16, 1984. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Kyoto Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1984
Date Received
May 31, 1984
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 Kyoto Diagnostics, Inc.

  • K861733 — ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS (July 25, 1986)
  • K843003 — GLUCOSE AUTO& STAT GA-1120 (September 28, 1984)
  • K842750 — OSMOTIC PRESSURE AUTO & STAT OM-6010 (August 17, 1984)
  • K841714 — KYOTEST 2V, URINE TEST REAGENT STRIP (May 31, 1984)
  • K841715 — KYOTEST UK URINE TEST REAGENT STRIP (May 31, 1984)
  • K841713 — KYOTEST UG URINE TEST REAGENT STRIP (May 31, 1984)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K840828 — KYOTEST 8V (May 14, 1984)
  • K840996 — URINE ANALYZER SYSTEM (May 1, 1984)
  • K840829 — KYOTEST UGK (April 19, 1984)

Other clearances for product code JRE

  • K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (March 11, 1996)
  • K941901 — MODEL 2721 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941903 — MODEL 2740 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)
  • K831213 — SPECIFIC GRAVITY INSTRUMENT (June 30, 1983)
  • K811342 — REAGENT STRIPS FOR URINALYSIS (September 1, 1981)

FDA data resources