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510(k) K812604

BIOVATION URINALYSIS REPORTER by Biovation, Inc. — Product Code JQP

K812604 is an FDA 510(k) premarket notification submitted by Biovation, Inc. for the device "BIOVATION URINALYSIS REPORTER". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Biovation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
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)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790862 — BIOVATION DIGITAL URINOMETER (June 28, 1979)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

Other clearances for product code JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)

FDA data resources