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510(k) K941905

MODEL 3461 CLINICAL REFRACTOMETER by Vee Gee Scientific, Inc. — Product Code JRE

K941905 is an FDA 510(k) premarket notification submitted by Vee Gee Scientific, Inc. for the device "MODEL 3461 CLINICAL REFRACTOMETER". The FDA issued a decision of Substantially Equivalent on December 13, 1994. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Vee Gee Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
April 19, 1994
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 Vee Gee Scientific, Inc.

  • 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)
  • K941904 — MODEL A300CL CLINICAL REFRACTOMETER (December 13, 1994)

Other clearances for product code JRE

  • K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (March 11, 1996)
  • 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)
  • 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