Home / 510(k) Clearances / K884623

510(k) K884623

SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE by Safe-Tec Clinical Products, Inc. — Product Code GIO

K884623 is an FDA 510(k) premarket notification submitted by Safe-Tec Clinical Products, Inc. for the device "SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE". The FDA issued a decision of Substantially Equivalent on December 1, 1988. The device falls under product code GIO (Tube, Collection, Capillary Blood), a Class I device regulated under 21 CFR 864.6150. Safe-Tec Clinical Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1988
Date Received
November 4, 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 Safe-Tec Clinical Products, Inc.

  • K890109 — SAFEPETTE DISPENSER (February 23, 1989)

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)
  • 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