FDA.report

510(k) K894031

Device
Pharmaseal Genetic Amniocentesis Tray
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K894031
Product code
HIO
Decision
Unknown (SESD)
Decision date
1989-08-04
Date received
1989-06-06
Regulation
884.1550
Classification name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
N

Related Records

Applicant Contact

Contact
T MERRICK
Address
27200 N. Tourney Rd. P.O. Box 5900 Valencia CA US 91355 91355

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIO

510(k)DeviceApplicantDecision date
K960203G.E. STERILE AMNIOCENTESIS TRAYGE Medical Systems1996-03-14
K955679RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAYContour Fabricators of Florida, Inc.1996-03-12
K914419AMNIOTEST(TM)Pro-Lab, Inc.1993-09-01
K922960VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLECameo, Inc.1992-11-05
K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.1992-04-27
K915863MEGA AMNIOCENTESIS KITMega Medical, Inc.1992-03-30
K904583SONO-VU US(TM)E-Z-Em, Inc.1991-06-24
K901643ISOFLO(TM) AMNIOCENTESIS TRAYHealthdyne Cardiovascular, Inc.1990-07-25
K900021PERCU-SET(TM)E-Z-Em, Inc.1990-03-29
K896031AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)Concord/Portex1990-01-12
K892846ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLECook Ob/Gyn1989-07-14
K890463ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAYCritical Specialties, Inc.1989-04-07
K862365NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURESwemed Laboratories, Inc.1986-07-07
K854725HURWITZ AMNIOCENTESIS NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic1986-03-17
K850632PMS AMNIOCENTESIS TRAY/KITProfessional Medical Services1985-05-22