Product code KFF— Hematology
ACTICHROME HEPARIN (ANTI-FIIA)
- Classification name
- Assay, Heparin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Total cleared
- 46
- First cleared
- Most recent
Market context for product code KFF
FDA has cleared devices under product code KFF between 1979 and 2022, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2017
- 2011
- 2009
- 2006
- 2002
- 2001
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
Top applicants under product code KFF
Recent clearances under product code KFF
- K213464 — HemosIL Liquid Anti-Xa
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
- K013305 — ENOXAPARIN TEST CARD
- K013637 — ACTICHROME HEPARIN (ANTI-FIIA)
- K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
- K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
- K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
- K983178 — COAMATIC HEPARIN
- K980242 — IL TEST HEPARIN
- K972209 — SPECTROLYSE HEPARIN (ANTI-IIA)
- K965076 — MDA HEPARIN ANTI-X ASSAY
- K952667 — CHROM Z-HEPARIN, CAT. NO 5242
- K952514 — COACUTE HEPARIN
- K943514 — THE HEPANORM HBPM/LMWH KIT
- K943519 — HBPM/LMWH CONTROL KIT
- K943520 — HEPARIN CONTROL KIT
- K943515 — ROTACHROM HEPARIN TEST KIT
- K943516 — ROTACHROM HBPM/LMWH TEST KIT
- K925433 — THE STACHROM HEPARIN ASSAY KIT
- K943517 — STACLOT HEPARIN TEST KIT
- K943283 — HEPARIN MANAGEMENT TEST CARD; HMT CARD
- K934274 — HEMOLAB HEPARICHROM ASSAY
- K935212 — IL TEST HEPARIN (XA), PN 84699-15
- K923499 — SPECTROLYSE HEPARIN KIT
- K925200 — BERICHROM HEPARIN
- K910181 — HITT BY HEMOCHRON(R)
- K910741 — HEPARIN CONTROLS, HIGH AND LOW
- K904003 — HEMOCHRON(R) HEPARIN RESPONSE TEST
- K903841 — ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
- K901874 — COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
- K900396 — ORTHOKROME* HEPARIN
- K884590 — HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
- K864211 — IL TEST 97575-15, HEPARIN ASSAY
- K854762 — HEPANORM CALIBRATION PLASMA SET
- K853239 — HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
- K850486 — GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
- K843201 — HEPARIN ACA ANALYTICAL TEST PACK
- K843202 — HEPARIN CALIBRATOR ACA
- K834024 — HEPARINOMETER
- K833891 — COATEST HEPARIN
- K832373 — DIACROM * HEPARIN
- K812424 — CI-TROL HEPARIN CONTROLS, LOW/HIGH
- K781479 — HEPARIN ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.