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510(k) K812970

S/P CAPILLARY TUBES, HEPARINIZED (3A) by American Dade — Product Code GIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 22, 1981
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 American Dade

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  • K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY (September 14, 1987)
  • K872789 — PARAMAX URINE/CSF CALIBRATOR (September 2, 1987)
  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

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)