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510(k) K791922

HARLECO BRAND CLINICARD LIPASE TEST SET by Dade, Baxter Travenol Diagnostics, Inc. — Product Code CET

K791922 is an FDA 510(k) premarket notification submitted by Dade, Baxter Travenol Diagnostics, Inc. for the device "HARLECO BRAND CLINICARD LIPASE TEST SET". The FDA issued a decision of Substantially Equivalent on November 27, 1979. The device falls under product code CET (Olive Oil Emulsion (Turbidimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. Dade, Baxter Travenol Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1979
Date Received
September 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Olive Oil Emulsion (Turbidimetric), Lipase
Device Class
Class I
Regulation Number
862.1465
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)
  • 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)
  • 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)

Other clearances for product code CET

  • K970124 — LIPASE REAGENT SET (COLIPASE METHOD) (March 6, 1997)
  • K940457 — LIPASE REAGENT SYSTEM (June 2, 1994)
  • K915706 — LIPASE REAGENT SET (February 18, 1992)
  • K901858 — MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (June 12, 1990)
  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K885078 — LIPASE SR LIQUID STABLE REAGENT SET (March 13, 1989)
  • K864438 — BECKMAN EPSILON(TM) LIPASE TEST KIT (March 12, 1987)
  • K862440 — PARAMAX LIPASE REAGENT (August 4, 1986)
  • K844240 — ENZYGNOST LIPASE TEST (February 12, 1985)
  • K823860 — NUCLIPASE (I125) PANCREATIC LIPASE (April 18, 1983)

FDA data resources