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510(k) K875275

WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER by Sterling Drug, Inc. — Product Code JTQ

K875275 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code JTQ (Bath, Incubators/Water, All), a Class I device regulated under 21 CFR 866.2540. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 24, 1987
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 Sterling Drug, Inc.

  • K901369 — GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II (June 5, 1990)
  • K896110 — BIOBRANE(R) II (November 28, 1989)
  • K840260 — PERIOGRAF DURAPATITE 40-60 MESH (April 5, 1984)
  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
  • K820164 — EMPTY STERILE CARPUJECT (February 24, 1982)
  • K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)
  • K780209 — DILUTION SPIKE (April 10, 1978)

Other clearances for product code JTQ

  • 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)
  • 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