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510(k) K930898

RADIAS AUTOMATED IMMUNOASSAY SYSTEM by Bio-Rad — Product Code JJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1993
Date Received
February 22, 1993
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

  • K972024 — CODA AUTOMATED EIA ANALYZER (July 30, 1997)
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  • K931970 — ABBOTT IMX2 ANALYER (June 16, 1993)
  • 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)