Amniotest(Tm)
FDA 510(k) K914419 · Pro-Lab, Inc.
510(k) numberK914419
Submission
- Device name
- Amniotest(Tm)
- Applicant
- Pro-Lab, Inc.
Ontario Canada M5m 1c9, CA - Received
- October 3, 1991
- Decision date
- September 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIO – Sampler, Amniotic Fluid (Amniocentesis Tray)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.1550
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960203 | G.E. Sterile Amniocentesis TrayHIO · Traditional | GE Medical Systems | 03/14/1996SE |
| K955679 | RNS Sterile, Disposable Amniocentesis TrayHIO · Traditional | Contour Fabricators of Florida, Inc. | 03/12/1996SE |
| K922960 | Various Cameo Med Amniocentesis Trays, DisposableHIO · Traditional | Cameo, Inc. | 11/05/1992SEKD |
| K921738 | Sono-Vu Us(Tm), ModificationHIO · Traditional | E-Z-Em, Inc. | 04/27/1992SE |
| K915863 | Mega Amniocentesis KitHIO · Traditional | Mega Medical, Inc. | 03/30/1992SEKD |
| K904583 | Sono-Vu Us(Tm)HIO · Traditional | E-Z-Em, Inc. | 06/24/1991SE |
| K901643 | Isoflo(Tm) Amniocentesis TrayHIO · Traditional | Healthdyne Cardiovascular, Inc. | 07/25/1990SE |
| K900021 | Percu-Set(Tm)HIO · Traditional | E-Z-Em, Inc. | 03/29/1990SE |
| K896031 | Amniotic Fluid Sampler (Amniocentesis Tray)HIO · Traditional | Concord/Portex | 01/12/1990SE |
| K894031 | Pharmaseal Genetic Amniocentesis TrayHIO · Traditional | Baxter Healthcare Corp | 08/04/1989SESD |
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| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was Amniotest(Tm) cleared by the FDA?
Amniotest(Tm) (K914419) received a 510(k) decision of Substantially Equivalent on September 1, 1993, 699 days after the submission was received.
What is the product code of K914419?
The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.