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510(k) K881262

CARAWAY TUBES, HEPARIN AND PLAIN by Helps Products, Inc. — Product Code GIO

K881262 is an FDA 510(k) premarket notification submitted by Helps Products, Inc. for the device "CARAWAY TUBES, HEPARIN AND PLAIN". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code GIO (Tube, Collection, Capillary Blood), a Class I device regulated under 21 CFR 864.6150. Helps Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
March 24, 1988
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 Helps Products, Inc.

  • K881188 — BLOOD PH CAPILLARY TUBES, HEPARIN (July 8, 1988)
  • K881186 — MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL (May 13, 1988)
  • K881187 — NATELSON TUBES, HEPARIN AND PLAIN (May 6, 1988)

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)
  • 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