Seradyn, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 12, 2007

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

K062966 · ORH

Chemistry · 105d

Cleared Sep 22, 2006

ARCHITECT CORTISOL ASSAY

K062204 · JFT

Chemistry · 52d

Cleared Jul 21, 2006

QMS TOBRAMYCIN

K060998 · LCR

Chemistry · 101d

Cleared Nov 18, 2005

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS

K051211 · NWM

Chemistry · 191d

Cleared Nov 03, 2004

ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)

K042307 · JIT

Chemistry · 70d

Cleared Feb 09, 2004

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

K033674 · LCP

Chemistry · 77d

Cleared Mar 11, 1994

VALPROIC ACID

K936208 · LEG

Chemistry · 72d

Cleared Mar 26, 1993

ELECTROPHORESIS CONTROL LEVEL 1

K925326 · JJY

Chemistry · 156d

Cleared Aug 30, 1991

QMS - DIGOXIN

K913562 · LCS

Chemistry · 21d

Cleared Feb 27, 1991

ELECTROPHORESIS CONTROL

K910160 · JIT

Chemistry · 43d

Cleared Feb 22, 1991

CK-MB IMMUNOASSAY CONTROL

K905623 · JJT

Chemistry · 70d

Cleared Nov 06, 1990

QMS TM- PHENYTOIN

K904815 · DIP

Chemistry · 13d

Cleared May 24, 1990

QUICK CHEM II

K901695 · JJQ

Chemistry · 44d

Cleared Mar 28, 1989

QMS(TM) - THEOPHYLLINE

K885263 · JQX

Chemistry · 95d

Cleared Jan 05, 1988

REAGENT A AND REAGENT B

K874413 · JIX

Chemistry · 69d