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510(k) K780972

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

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

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  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
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  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code JJI

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  • 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)