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510(k) K930898

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

K930898 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "RADIAS AUTOMATED IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1993. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500. Bio-Rad has at least 10 other 510(k) clearances on record.

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

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

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)
  • 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)

FDA data resources