Femexam Testcard
FDA 510(k) K962718 · Litmus Concepts, Inc.
510(k) numberK962718
Submission
- Device name
- Femexam Testcard
- Applicant
- Litmus Concepts, Inc.
Front Royal, VA, US - Received
- July 12, 1996
- Decision date
- February 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K091287 | Vs-Sense TestCEN · Traditional | Common Sense , Ltd. | 08/31/2009SE |
| K071100 | Amniscreen Home Detection Liner KitCEN · Traditional | Common Sense , Ltd. | 10/15/2007SE |
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | Germaine Laboratories, Inc. | 10/26/2005SE |
| K040008 | Quickvue Advance PH and Amines GLL TestCEN · Traditional | Quidel Corp. | 04/29/2004SE |
| K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsCEN · Traditional | Uridynamics, Inc. | 04/14/2003SE |
| K840827 | Kyotest 5VCEN · Traditional | Kyoto Diagnostics, Inc. | 05/14/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | Syn-Kit, Inc. | 06/12/1983SE |
| K830979 | Helena Biostrip PHCEN · Traditional | Helena Laboratories | 05/05/1983SE |
| K830091 | Lith a Test TMCEN · Traditional | Lenal Creative Approaches, Inc. | 02/15/1983SE |
| K822241 | FOLATE/B12 Duo-Bead RadioassayCEN · Traditional | Abbott Laboratories | 10/26/1982SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K964015 | Indicard TestMJM · Traditional | 06/19/1997SE |
Questions and answers
When was Femexam Testcard cleared by the FDA?
Femexam Testcard (K962718) received a 510(k) decision of Substantially Equivalent on February 7, 1997, 210 days after the submission was received.
What is the product code of K962718?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.