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510(k) K923844

LYRIS 100/120 LABORATORY INFORMATION SYSTEM by Biovation, Inc. — Product Code JJQ

K923844 is an FDA 510(k) premarket notification submitted by Biovation, Inc. for the device "LYRIS 100/120 LABORATORY INFORMATION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 1992. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Biovation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1992
Date Received
July 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

Other clearances by Biovation, Inc.

  • K925528 — BIOVATION K-MANAGER (February 5, 1993)
  • K915071 — DIFFERENTIAL COUNTING BOARD (January 17, 1992)
  • K853026 — BIOVATION MAX DATA MANAGEMENT SYSTEM (August 2, 1985)
  • K842401 — CHEMISTRY CONSOLE (September 4, 1984)
  • K831830 — LYRIS MODULAR INFO SYSTEM (June 25, 1984)
  • K821534 — HEMATOLOGY DATA MANAGEMENT SYS (June 10, 1982)
  • K812604 — BIOVATION URINALYSIS REPORTER (October 2, 1981)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790862 — BIOVATION DIGITAL URINOMETER (June 28, 1979)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

Other clearances for product code JJQ

  • K013371 — UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (December 21, 2001)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (February 4, 1998)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K962113 — ANTHOS PHACTS VERSION MICROPLATE READER (November 5, 1996)
  • K961183 — CBI 7520 READER (August 2, 1996)
  • K962166 — ORIGEN ANALYZER (July 31, 1996)
  • K955077 — ANTHOS 2010 READER (December 4, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)

FDA data resources