510(k) K914419
- Device
- AMNIOTEST(TM)
- Applicant
- PRO-LAB, INC.
- 510(k) number
- K914419
- Product code
- HIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-01
- Date received
- 1991-10-03
- Regulation
- 884.1550
- Classification name
- Sampler, Amniotic Fluid (amniocentesis Tray)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOACHIM SPARKUHL
- Address
- 76 Glengarry Ave. Toronto Ontario Canada M5m 1c9 CA
FDA Registration Numbers#
- 9610649
- 9616088
- 2433012
- 1061124
- 3010132111
- 1047429
- 8010383
- 3010155661
- 3003528228
- 3005012805
- 1423537
- 3035642068
- 1625425
- 1720929
- 3009888344
- 3010291427
- 3013557562
- 3013152643
- 1820334
- 1928237
- 3007329020
- 1420054
- 1643817
- 9681709
- 1423507
- 3003995932
- 1054241
- 3006405073
- 1836161
- 1043214
- 3004111573
- 1055236
- 3018348
- 3015895045
- 1030451
- 3030446844
- 2431166
- 1825146
- 1319639
- 2029015
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960203 | G.E. STERILE AMNIOCENTESIS TRAY | GE Medical Systems | 1996-03-14 |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Contour Fabricators of Florida, Inc. | 1996-03-12 |
| K922960 | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | Cameo, Inc. | 1992-11-05 |
| K921738 | SONO-VU US(TM), MODIFICATION | E-Z-Em, Inc. | 1992-04-27 |
| K915863 | MEGA AMNIOCENTESIS KIT | Mega Medical, Inc. | 1992-03-30 |
| K904583 | SONO-VU US(TM) | E-Z-Em, Inc. | 1991-06-24 |
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | Healthdyne Cardiovascular, Inc. | 1990-07-25 |
| K900021 | PERCU-SET(TM) | E-Z-Em, Inc. | 1990-03-29 |
| K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | Concord/Portex | 1990-01-12 |
| K894031 | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | Baxter Healthcare Corp | 1989-08-04 |
| K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | Cook Ob/Gyn | 1989-07-14 |
| K890463 | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | Critical Specialties, Inc. | 1989-04-07 |
| K862365 | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | Swemed Laboratories, Inc. | 1986-07-07 |
| K854725 | HURWITZ AMNIOCENTESIS NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-03-17 |
| K850632 | PMS AMNIOCENTESIS TRAY/KIT | Professional Medical Services | 1985-05-22 |
Legacy Summary#
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FDA Review#
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