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510(k) K780972

QUICKRATE REACTION RATE ANALYZER by Olympus Corp. — Product Code JJI

K780972 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "QUICKRATE REACTION RATE ANALYZER". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Enzyme, For Clinical Use
Device Class
Class I
Regulation Number
862.2500
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 JJI

  • K972024 — CODA AUTOMATED EIA ANALYZER (July 30, 1997)
  • K944731 — ABBOTT IMX 2 ANALYZER (December 19, 1994)
  • K931970 — ABBOTT IMX2 ANALYER (June 16, 1993)
  • K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEM (April 21, 1993)
  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)
  • K771591 — MINISTAT-S CHEMISTRY ANALYZER (September 20, 1977)
  • K770401 — LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (April 26, 1977)

FDA data resources