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510(k) K973938

ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER by Sfri, Inc. — Product Code JJQ

K973938 is an FDA 510(k) premarket notification submitted by Sfri, Inc. for the device "ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER". The FDA issued a decision of Substantially Equivalent on February 4, 1998. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1998
Date Received
October 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K953005 — BILI-METER (September 28, 1995)

FDA data resources