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510(k) K792723

BLOOD FLUID FILTERS by Dade, Baxter Travenol Diagnostics, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
December 31, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
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)
  • 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)
  • K790571 — QUIK-STAIN (April 23, 1979)

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