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510(k) K920942

OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER by Olympus Corp. — Product Code JJG

K920942 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 10, 1992. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
February 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code JJG

  • K972409 — AG CHEMISTRY ANALYZER SYSTEM (August 28, 1997)
  • K942782 — PICCOLO(TM) (March 13, 1995)
  • K934592 — EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (April 6, 1994)
  • K910222 — COBAS ALPHA (February 27, 1991)
  • K903626 — BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (October 15, 1990)
  • K893854 — COBAS FARA II CENTRIFUGAL ANALYZER (August 3, 1989)
  • K893641 — COBAS FARA CENTRIFUGAL ANALYZER (July 20, 1989)
  • K885203 — TECHNICON DAX(TM) SYSTEM (March 28, 1989)
  • K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (June 11, 1987)
  • K871838 — BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (May 26, 1987)

FDA data resources