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510(k) K893810

IMMUNO-WASH AUTOMATED TUBE WASHER by Ocean Scientific, Inc. — Product Code JQW

K893810 is an FDA 510(k) premarket notification submitted by Ocean Scientific, Inc. for the device "IMMUNO-WASH AUTOMATED TUBE WASHER". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Ocean Scientific, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
May 22, 1989
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

Other clearances by Ocean Scientific, Inc.

  • K873638 — MICRO-CHEM ANALYZER (September 29, 1987)
  • K864731 — OCEAN SCIENTIFIC VDRL TEST (March 10, 1987)
  • K863976 — OCEAN SCIENTIFIC VACUTEST (October 24, 1986)
  • K860987 — MINI-CHEM ANALYZER (May 5, 1986)
  • K840340 — CHEM-STAT ANALYZER (March 23, 1984)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • 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