Amnisure Fetal Membranes Rupture Test Model FMRT1
FDA 510(k) K030849 · N-Dia, Inc.
510(k) numberK030849
Submission
- Device name
- Amnisure Fetal Membranes Rupture Test Model FMRT1
- Applicant
- N-Dia, Inc.
New York, NY, US - Received
- March 17, 2003
- Decision date
- February 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
Questions and answers
When was Amnisure Fetal Membranes Rupture Test Model FMRT1 cleared by the FDA?
Amnisure Fetal Membranes Rupture Test Model FMRT1 (K030849) received a 510(k) decision of Substantially Equivalent on February 2, 2004, 322 days after the submission was received.
What is the product code of K030849?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.