Product code HIO
- Device name
- Sampler, Amniotic Fluid (Amniocentesis Tray)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.1550
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K914419 | AMNIOTEST(TM) | Pro-Lab, Inc. | 1993-09-01 |
| 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 |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Universal Medical Instrument Corp. | 1985-01-31 |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | Universal Medical Instrument Corp. | 1983-01-18 |
| K802666 | APTEK ULTRASOUND PROCEDURE TRAY | Aptek , Ltd. | 1980-11-26 |
| K761230 | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | 1976-12-17 |
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| 10628429001223 | AmnioTest (Nitrazine yellow swab) | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10628429001254 | AmnioTest Colour Cards | PRO-LAB, INCORPORATED | 2022-12-26 |
| 10195594770228 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-10-27 |
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