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510(k) K894851

TRU-TRAX by Humagen, Inc. — Product Code GIO

K894851 is an FDA 510(k) premarket notification submitted by Humagen, Inc. for the device "TRU-TRAX". The FDA issued a decision of Substantially Equivalent on September 29, 1989. The device falls under product code GIO (Tube, Collection, Capillary Blood), a Class I device regulated under 21 CFR 864.6150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
July 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Collection, Capillary Blood
Device Class
Class I
Regulation Number
864.6150
Review Panel
HE
Submission Type

Other clearances for product code GIO

  • K972969 — QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (September 22, 1997)
  • K941291 — MONOJECT SAMPLETTE SEPARATOR TUBE (October 27, 1994)
  • K885324 — HEMA(PRO)TEC(TION) (February 17, 1989)
  • K885138 — CAPILLARY TUBE, BLOOD COLLECTION (February 7, 1989)
  • K884623 — SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (December 1, 1988)
  • K881262 — CARAWAY TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K881187 — NATELSON TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K875061 — MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (January 12, 1988)
  • K873647 — VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (October 20, 1987)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)

FDA data resources