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510(k) K842311

CHEMISTRY ANALYZER, GEN. PURPOSE by Hml Inc/Biotechnology Transfer — Product Code JJQ

K842311 is an FDA 510(k) premarket notification submitted by Hml Inc/Biotechnology Transfer for the device "CHEMISTRY ANALYZER, GEN. PURPOSE". The FDA issued a decision of Substantially Equivalent on July 25, 1984. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Hml Inc/Biotechnology Transfer has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1984
Date Received
June 12, 1984
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 Hml Inc/Biotechnology Transfer

  • K843000 — MICRO ORGANISM GROWTH SYS-M1000 (February 6, 1985)
  • K842310 — HEMATOLOGY ANALYZER (September 6, 1984)

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