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510(k) K790862

BIOVATION DIGITAL URINOMETER by Biovation, Inc. — Product Code JRE

K790862 is an FDA 510(k) premarket notification submitted by Biovation, Inc. for the device "BIOVATION DIGITAL URINOMETER". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Biovation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 7, 1979
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 Biovation, Inc.

  • K925528 — BIOVATION K-MANAGER (February 5, 1993)
  • K923844 — LYRIS 100/120 LABORATORY INFORMATION SYSTEM (December 11, 1992)
  • K915071 — DIFFERENTIAL COUNTING BOARD (January 17, 1992)
  • K853026 — BIOVATION MAX DATA MANAGEMENT SYSTEM (August 2, 1985)
  • K842401 — CHEMISTRY CONSOLE (September 4, 1984)
  • K831830 — LYRIS MODULAR INFO SYSTEM (June 25, 1984)
  • K821534 — HEMATOLOGY DATA MANAGEMENT SYS (June 10, 1982)
  • K812604 — BIOVATION URINALYSIS REPORTER (October 2, 1981)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

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)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K831213 — SPECIFIC GRAVITY INSTRUMENT (June 30, 1983)

FDA data resources