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510(k) K931970

ABBOTT IMX2 ANALYER by Abbott Laboratories — Product Code JJI

K931970 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT IMX2 ANALYER". The FDA issued a decision of Substantially Equivalent on June 16, 1993. The device falls under product code JJI (Analyzer, Enzyme, For Clinical Use), a Class I device regulated under 21 CFR 862.2500. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1993
Date Received
April 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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  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

Other clearances for product code JJI

  • K972024 — CODA AUTOMATED EIA ANALYZER (July 30, 1997)
  • K944731 — ABBOTT IMX 2 ANALYZER (December 19, 1994)
  • K930898 — RADIAS AUTOMATED IMMUNOASSAY SYSTEM (April 21, 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