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510(k) K802319

HEMOTEMP TM by Marion Laboratories, Inc. — Product Code KSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refrigerator, Freezer, Blood Storage
Device Class
Class II
Regulation Number
864.9700
Review Panel
HE
Submission Type

Other clearances by Marion Laboratories, Inc.

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  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (May 27, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)

Other clearances for product code KSE

  • K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 (December 2, 1988)
  • K813327 — SEPCOR TEMPERATURE MONITOR (December 31, 1981)
  • K800667 — MONITEMP BLOOD PACK TEMP. MONITOR (April 16, 1980)