Product code GFO— Hematology
APTT REAGENT
- Classification name
- Activated Partial Thromboplastin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Total cleared
- 52
- First cleared
- Most recent
Market context for product code GFO
FDA has cleared devices under product code GFO between 1976 and 2026, filed by 32 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- 2026
- 2020
- 2016
- 2006
- 2005
- 2002
- 1999
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
Top applicants under product code GFO
Recent clearances under product code GFO
- K253957 — HemosIL Silica Clotting Time
- K193556 — Cryocheck Hex LA
- K160445 — HemosIL Silica Clotting Time
- K053111 — STA-CEPHASCREEN KIT
- K060688 — HEMOSIL SYNTHASIL
- K050221 — HEMOSIL SILICA CLOTTING TIME
- K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
- K014028 — CARESIDE APTT
- K014008 — HEMOCHRON JR. CITRATE APTT CUVETTE
- K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
- K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
- K972831 — HEMOCHRON CITRATE APTT
- K973306 — IL TEST APTT-SP
- K961892 — SPECKTIN-LA TEST SET
- K955638 — SYNTHAFAX APTT REAGENT
- K955450 — PATHROMTIN SL
- K953981 — SYNTHASIL APTT REAGENT
- K935169 — APTT-ES
- K934351 — APTT-ES REAGENT
- K932011 — PATHROMTIN
- K926012 — ACS APCT REAGENT, MODIFIED
- K924637 — HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
- K924638 — HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT
- K923731 — STACLOT LA TEST KIT
- K921396 — PLATELIN L
- K921223 — ACS FREEZE-DRIED APTT REAGENT
- K921118 — ACS APCT REAGENT
- K915418 — ELLAGIC ACID APTT REAGENT
- K915344 — HEMOCHRON ONESTEP APTT TEST
- K911994 — HEMOCHRON(R) APTT, MODIFICATION
- K903531 — ANTICARDIOLIPIN ANTIBODY TEST SYSTEM
- K905301 — THE THERATEST ACA TEST
- K904341 — APTT REAGENT
- K902556 — ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K900049 — APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
- K896545 — ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
- K895255 — APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
- K892209 — APTT BY HEMOCHRON(R)
- K891015 — COAG-1 APTT TEST CARD
- K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
- K891337 — THROMBOSCREEN APTT REAGENT
- K890619 — EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
- K890052 — BIOTRACK APTT REAGENT CARTRIDGE
- K884856 — APTT REAGENT
- K884702 — EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
- K884485 — KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
- K882325 — UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K881068 — CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K820835 — ALUMINA SILICA-ACTIVATED PARTIAL THROM
- K781104 — PLASMA COAGULATION CONT., ABNORMAL
- K760918 — HEPARIN CONTROL PLASMA
- K760318 — ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.