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510(k) K882677

STAT-20 FLUOROMETER by Weaver Medical — Product Code JZT

K882677 is an FDA 510(k) premarket notification submitted by Weaver Medical for the device "STAT-20 FLUOROMETER". The FDA issued a decision of Substantially Equivalent on July 12, 1988. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1988
Date Received
June 28, 1988
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 for product code JZT

  • K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (September 5, 1996)
  • K883349 — QLIA IMMUNOCHEMISTRY SYSTEM (September 7, 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