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510(k) K892060

CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM by Syva Co. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1989
Date Received
March 29, 1989
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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  • 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)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)
  • K871853 — V-MARC 88A COMPUTER (July 16, 1987)