Medical Device Manufacturer · US , Mchenry , IL

Hyland Therapeutic Div., Travenol Laboratories

44 submissions · 44 cleared · Since 1976
44
Total
44
Cleared
0
Denied

Hyland Therapeutic Div., Travenol Laboratories — FDA 510(k) Submissions

Hyland Therapeutic Div., Travenol Laboratories has submitted 44 FDA 510(k) premarket notifications since 1976, of which 44 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Multi-analyte Mixture, Activated Partial Thromboplastin, Test, Leukocyte Typing, Complement C1q, Antigen, Antiserum, Control, Drug Mixture Control Materials . Use the specialty filter in the sidebar to narrow results.

44 devices
1–12 of 44
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835 · GFO Activated Partial... · Hematology
Apr 1982 31d
HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM
K820192 · GRP Antisera, All Types, H.... · Microbiology
Mar 1982 45d
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · JIW Calibrator, Surrogate · Immunology
Aug 1981 12d
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078 · DIF Drug Mixture Control... · Chemistry
Feb 1981 20d
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077 · DIF Drug Mixture Control... · Chemistry
Jan 1981 15d
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
K802610 · DER Alpha-1-lipoprotein,... · Immunology
Jan 1981 76d
LOW IONIC STRENGTH SOLUTION (LISS)
K791113 · KSG Media, Potentiating For... · Hematology
Jun 1979 13d
TEST CELLS
K790249 · KSF Kit, Quality Control For... · Hematology
May 1979 97d
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · CEE Radioimmunoassay,... · Chemistry
Aug 1978 44d
AUTOMATED ENZYME
K780962 · KSK Solution, Stabilized Enzyme · Hematology
Jul 1978 45d
DILUTOR TRANSPORTER
K780785 · JQW Station, Pipetting And... · Chemistry
Jun 1978 33d
LAS-R HUMAN IGE TEST
K780753 · DGC Ige, Antigen, Antiserum,... · Immunology
Jun 1978 29d

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