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510(k) K830227

AUTOMATED ELISA READER LBI 300 by Bionetic Laboratory Products — Product Code JTQ

K830227 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "AUTOMATED ELISA READER LBI 300". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
January 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Incubators/Water, All
Device Class
Class I
Regulation Number
866.2540
Review Panel
MI
Submission Type

Other clearances by Bionetic Laboratory Products

  • K833637 — VZV BIO-ENZABEAD SCREEN KIT (February 10, 1984)
  • K832900 — IMMUNOENZYME TEST SYS-DETECT-IGM ANTI (November 14, 1983)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K831760 — LEGIONELLA IFA KIT I (August 8, 1983)
  • K830820 — LEGIONELLA DFA KIT I (June 8, 1983)
  • K831133 — AMEBIASIS BIO-ENZABEAD SCREEN KIT (June 8, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)

Other clearances for product code JTQ

  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K831592 — ANHYDRIC INCUBATORS, CULTURE INCUBATOR (June 16, 1983)
  • K830322 — C.A.T. REAGENT KIT (March 28, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K822564 — WATER BATH (September 14, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)
  • K812340 — TITERTEK MICROPLATE INCUBATOR (September 23, 1981)
  • K801462 — SPOR-O-THERM (July 28, 1980)
  • K792060 — TEMPTRONIC 100 WATER BATH (December 4, 1979)

FDA data resources