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510(k) K831830

LYRIS MODULAR INFO SYSTEM by Biovation, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
June 7, 1983
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

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  • K853026 — BIOVATION MAX DATA MANAGEMENT SYSTEM (August 2, 1985)
  • K842401 — CHEMISTRY CONSOLE (September 4, 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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