Pregnancy-Skreen
FDA 510(k) K050328 · Biochemical Diagnostic, Inc.
510(k) numberK050328
Submission
- Device name
- Pregnancy-Skreen
- Applicant
- Biochemical Diagnostic, Inc.
Edgewood, NY, US - Received
- February 9, 2005
- Decision date
- March 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121122 | Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlDIF · Traditional | 07/03/2012SE |
| K925586 | Detectabuse(Tm)DIF · Traditional | 12/28/1992SE |
| K904181 | Anti-Gbm Antibodies Quantitative KitDBL · Traditional | 09/10/1991SE |
| K841831 | Cannu-Skreen-PreliminaryDKE · Traditional | 07/06/1984SE |
Questions and answers
When was Pregnancy-Skreen cleared by the FDA?
Pregnancy-Skreen (K050328) received a 510(k) decision of Substantially Equivalent on March 29, 2005, 48 days after the submission was received.
What is the product code of K050328?
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.