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510(k) K881186

MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL by Helps Products, Inc. — Product Code GHY

K881186 is an FDA 510(k) premarket notification submitted by Helps Products, Inc. for the device "MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code GHY (Hematocrit, Tube, Rack, Sealer, Holder), a Class II device regulated under 21 CFR 864.6400. Helps Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hematocrit, Tube, Rack, Sealer, Holder
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type

Other clearances by Helps Products, Inc.

  • K881188 — BLOOD PH CAPILLARY TUBES, HEPARIN (July 8, 1988)
  • K881262 — CARAWAY TUBES, HEPARIN AND PLAIN (May 6, 1988)
  • K881187 — NATELSON TUBES, HEPARIN AND PLAIN (May 6, 1988)

Other clearances for product code GHY

  • K883185 — SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (August 18, 1988)

FDA data resources