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510(k) K802319

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

K802319 is an FDA 510(k) premarket notification submitted by Marion Laboratories, Inc. for the device "HEMOTEMP TM". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code KSE (Refrigerator, Freezer, Blood Storage), a Class II device regulated under 21 CFR 864.9700. Marion Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • 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)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874552 — ENVISAN PAD (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)

FDA data resources