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510(k) K853379

PLATE INCUBATOR by Scientific Sales Intl., Inc. — Product Code JTQ

K853379 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "PLATE INCUBATOR". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
August 12, 1985
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 Scientific Sales Intl., Inc.

  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K940799 — FLEXGUIDE (August 18, 1994)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K853285 — MYWASHER 5 (October 4, 1985)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K802416 — SALEM/RESCE INTUBATION GUIDE (October 23, 1980)

Other clearances for product code JTQ

  • K875275 — WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER (January 27, 1988)
  • 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)
  • K830227 — AUTOMATED ELISA READER LBI 300 (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