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510(k) K800698

AUTOFLUOR SYSTEM by California Immuno Diagnostic, Inc. — Product Code JZT

K800698 is an FDA 510(k) premarket notification submitted by California Immuno Diagnostic, Inc. for the device "AUTOFLUOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. California Immuno Diagnostic, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1980
Date Received
March 28, 1980
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 California Immuno Diagnostic, Inc.

  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K823445 — ALKPHOR SYSTEM (December 28, 1982)

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