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510(k) K941498

BIOMEK SL WITH BIOMEK SL INCUBATOR by Beckman Analytical and Biotechnology Development — Product Code JQW

K941498 is an FDA 510(k) premarket notification submitted by Beckman Analytical and Biotechnology Development for the device "BIOMEK SL WITH BIOMEK SL INCUBATOR". The FDA issued a decision of Substantially Equivalent on July 14, 1994. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1994
Date Received
March 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

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  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)

FDA data resources