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510(k) K962499

ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER by Bartels, Inc. — Product Code JZT

K962499 is an FDA 510(k) premarket notification submitted by Bartels, Inc. for the device "ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER". The FDA issued a decision of Substantially Equivalent on September 5, 1996. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Bartels, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1996
Date Received
June 26, 1996
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 Bartels, Inc.

Other clearances for product code JZT

  • 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)
  • K852240 — SMS, SCREEN MACHINE SYSTEM (June 11, 1985)
  • 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