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510(k) K843892

MICRO HEMATOCRIT CAPILLARY TUBES by Abco Dealers, Inc. — Product Code GIO

K843892 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "MICRO HEMATOCRIT CAPILLARY TUBES". The FDA issued a decision of Substantially Equivalent on November 13, 1984. The device falls under product code GIO (Tube, Collection, Capillary Blood), a Class I device regulated under 21 CFR 864.6150. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1984
Date Received
October 3, 1984
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 by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

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)
  • K894851 — TRU-TRAX (September 29, 1989)
  • 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)
  • K881187 — NATELSON TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K881262 — CARAWAY 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)

FDA data resources