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510(k) K780912

ADJUSTABLE DISPENSOR by Oxford Laboratories, Inc. — Product Code JQW

K780912 is an FDA 510(k) premarket notification submitted by Oxford Laboratories, Inc. for the device "ADJUSTABLE DISPENSOR". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Oxford Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1978
Date Received
June 5, 1978
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 Oxford Laboratories, Inc.

  • K760144 — SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760146 — SERUM, IGA GOAT ANTI-HUMAN ACID (July 20, 1976)
  • K760079 — REAGENT, THYROXINE T4 (#210) (July 20, 1976)
  • K760147 — SERUM, IGM ANTI-HUMAN ACID (July 20, 1976)
  • K760078 — REAGENT, RIA TRIIODOTHYRONINE T3 (#200) (July 20, 1976)
  • K760148 — SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN (July 20, 1976)
  • K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (July 20, 1976)
  • K760145 — SERUM, IGG GOAT ANTI-HUMAN ACID (July 19, 1976)

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