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510(k) K831592

ANHYDRIC INCUBATORS, CULTURE INCUBATOR by Boekel Industries, Inc. — Product Code JTQ

K831592 is an FDA 510(k) premarket notification submitted by Boekel Industries, Inc. for the device "ANHYDRIC INCUBATORS, CULTURE INCUBATOR". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Boekel Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
May 17, 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 Boekel Industries, Inc.

  • K823766 — BLOOD GAS INCUBATOR #260650 (February 18, 1983)
  • K822564 — WATER BATH (September 14, 1982)

Other clearances for product code JTQ

  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • 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)
  • 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