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510(k) K831870

ALLERGENETICS FLUORO-FAST READER by Axonics, Inc. — Product Code JZT

K831870 is an FDA 510(k) premarket notification submitted by Axonics, Inc. for the device "ALLERGENETICS FLUORO-FAST READER". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Axonics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 10, 1983
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 Axonics, Inc.

  • K843712 — AUDIT TM V (April 5, 1985)
  • K833298 — AUDIT V AX 135 (December 1, 1983)
  • K822335 — AUDIT (February 7, 1983)
  • K823494 — TOTAL IGE-FAST TEST (January 14, 1983)

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)
  • 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)

FDA data resources