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510(k) K915503

FIBRINOGEN FDP CONTROL by Cala Diagnostics — Product Code DAP

K915503 is an FDA 510(k) premarket notification submitted by Cala Diagnostics for the device "FIBRINOGEN FDP CONTROL". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Cala Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1992
Date Received
December 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

Other clearances by Cala Diagnostics

  • K944246 — CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (October 31, 1994)
  • K944247 — CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (October 31, 1994)
  • K944243 — CARDIOCHEX (October 27, 1994)
  • K930874 — LD-1 CONTROL-LEVEL 1 & 2 (April 22, 1993)
  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (April 13, 1993)
  • K926015 — CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (December 28, 1992)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)
  • K864456 — CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (May 6, 1987)

Other clearances for product code DAP

  • K172903 — HemosIL D-Dimer HS 500 (November 22, 2017)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K160885 — HemosIL D-Dimer HS (October 27, 2016)
  • K151534 — HemosIL D-Dimer HS (July 6, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K112818 — VIDAS D-DIMER EXCLUSION II (DEX2) (July 31, 2012)
  • K110303 — STRATUS CS ACUTE CARE D-DIMER (May 16, 2011)
  • K093626 — INNOVANCE D-DIMER, MODEL OPBP09 (November 29, 2010)
  • K090264 — HEMOSIL D-DIMER HS 500, CONTROLS (February 5, 2010)
  • K091916 — INNOVANCE D-DIMER, MODEL OPBP09 (October 29, 2009)

FDA data resources