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510(k) K852240

SMS, SCREEN MACHINE SYSTEM by Pandex Laboratories, Inc. — Product Code JZT

K852240 is an FDA 510(k) premarket notification submitted by Pandex Laboratories, Inc. for the device "SMS, SCREEN MACHINE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Pandex Laboratories, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
May 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer
Device Class
Class I
Regulation Number
866.4520
Review Panel
IM
Submission Type

Other clearances by Pandex Laboratories, Inc.

  • K864699 — FLUORESCENCE CONCENTRATION ANALYZER (FCA) (December 22, 1986)

Other clearances for product code JZT

  • K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (September 5, 1996)
  • K883349 — QLIA IMMUNOCHEMISTRY SYSTEM (September 7, 1988)
  • K882677 — STAT-20 FLUOROMETER (July 12, 1988)
  • K864699 — FLUORESCENCE CONCENTRATION ANALYZER (FCA) (December 22, 1986)
  • K863434 — THE FIAX 5000 FLUOROMETER (October 29, 1986)
  • K862674 — PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (August 15, 1986)
  • K842049 — FLUOROSKAN (December 3, 1984)
  • K843356 — FIAX 100 FLUOROMETER (September 17, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)
  • K831870 — ALLERGENETICS FLUORO-FAST READER (August 12, 1983)

FDA data resources