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510(k) K760719

UNIFORM DROP SIZE PASTEUR TYPE PIPETS by Dade, Baxter Travenol Diagnostics, Inc. — Product Code GJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1976
Date Received
September 27, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pipette, Quantitative, Hematology
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

Other clearances by Dade, Baxter Travenol Diagnostics, Inc.

  • K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (March 5, 1980)
  • K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL, (February 13, 1980)
  • K792723 — BLOOD FLUID FILTERS (January 21, 1980)
  • K792607 — T3 UPTAKE (T3U) REAGENTS (January 16, 1980)
  • K792443 — TSH RADIOIMMUNOASSAY (December 27, 1979)
  • K792442 — FERRITIN RADIOIMMUNOASSAY (December 18, 1979)
  • K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET (November 27, 1979)
  • K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (November 13, 1979)
  • K790767 — IMMU-TEK AUTOMATIC CENTRIFUGE (May 23, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)

Other clearances for product code GJG

  • K831079 — LIQUIPETTE (April 28, 1983)
  • K781891 — PIPETTES, PLASTIC DISPOSABLE (November 15, 1978)
  • K780237 — DISPOSABLE CONTROLLED DROP PASTEUR PIPET (March 9, 1978)