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510(k) K831213

SPECIFIC GRAVITY INSTRUMENT by Iris — Product Code JRE

K831213 is an FDA 510(k) premarket notification submitted by Iris for the device "SPECIFIC GRAVITY INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
April 14, 1983
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 for product code JRE

  • K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (March 11, 1996)
  • K941906 — MODEL 2730 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941901 — MODEL 2721 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941903 — MODEL 2740 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941904 — MODEL A300CL CLINICAL REFRACTOMETER (December 13, 1994)
  • K941905 — MODEL 3461 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941902 — MODEL 3471 CLINICAL REFRACTOMETER (December 13, 1994)
  • K891681 — DILECTRON URINARY CONDUCTIVITY PROBE (May 1, 1990)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K811342 — REAGENT STRIPS FOR URINALYSIS (September 1, 1981)

FDA data resources