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510(k) K913130

STRATUS IINTELLECT IMMUNOASSAY SYSTEM by Baxter Healthcare Corp — Product Code KHO

K913130 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STRATUS IINTELLECT IMMUNOASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
July 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code KHO

  • K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, (January 20, 2012)
  • K973547 — TRIAGE STATMETER (January 13, 1998)
  • K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (June 27, 1997)
  • K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM (October 18, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K935047 — AUTO DELFIA (May 23, 1994)
  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)

FDA data resources