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510(k) K812340

TITERTEK MICROPLATE INCUBATOR by Flow Laboratories, Inc. — Product Code JTQ

K812340 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "TITERTEK MICROPLATE INCUBATOR". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 18, 1981
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 Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

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)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K822564 — WATER BATH (September 14, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)
  • K801462 — SPOR-O-THERM (July 28, 1980)
  • K792060 — TEMPTRONIC 100 WATER BATH (December 4, 1979)

FDA data resources