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510(k) K853026

BIOVATION MAX DATA MANAGEMENT SYSTEM by Biovation, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
July 18, 1985
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)
  • 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)
  • K790862 — BIOVATION DIGITAL URINOMETER (June 28, 1979)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

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  • 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)