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510(k) K790767

IMMU-TEK AUTOMATIC CENTRIFUGE by Dade, Baxter Travenol Diagnostics, Inc. — Product Code KSN

K790767 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "IMMU-TEK AUTOMATIC CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on May 23, 1979. The device falls under product code KSN (Centrifuge, Cell-Washing, Automated For Immuno-Hematology), a Class II device regulated under 21 CFR 864.9285. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1979
Date Received
April 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Device Class
Class II
Regulation Number
864.9285
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)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790571 — QUIK-STAIN (April 23, 1979)

FDA data resources