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510(k) K972024

CODA AUTOMATED EIA ANALYZER by Bio-Rad — Product Code JJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1997
Date Received
June 2, 1997
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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Other clearances for product code JJI

  • K944731 — ABBOTT IMX 2 ANALYZER (December 19, 1994)
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  • K790073 — ANALYZER, IMPACT 100 (February 22, 1979)
  • K780972 — QUICKRATE REACTION RATE ANALYZER (August 14, 1978)
  • K771591 — MINISTAT-S CHEMISTRY ANALYZER (September 20, 1977)
  • K770401 — LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (April 26, 1977)