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510(k) K895240

DELFIA PLATE FLUOROMETER 1232 by Pharmacia, Inc. — Product Code KHO

K895240 is an FDA 510(k) premarket notification submitted by Pharmacia, Inc. for the device "DELFIA PLATE FLUOROMETER 1232". The FDA issued a decision of Substantially Equivalent on October 4, 1989. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Pharmacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
August 21, 1989
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

Other clearances by Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

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