Phenylalanine Test Kit
FDA 510(k) K943547 · Isolab, Inc.
510(k) numberK943547
Submission
- Device name
- Phenylalanine Test Kit
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- July 21, 1994
- Decision date
- January 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JNB – Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1555
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JNB
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|---|---|---|---|
| K021541 | Neogram Pku Tandem Mass Spectrometry KitJNB · Traditional | Perkinelmer Life Sciences | 10/28/2002SE |
| K003584 | Neolynx Screening Application ManagerJNB · Traditional | Micromass, Inc. | 03/19/2001SE |
| K000754 | Quantase Phenylalanine Screening Assay 500 Test KitJNB · Traditional | Quantase , Ltd. | 06/19/2000SE |
| K984463 | Quantase Phe/Gal Screening AssayJNB · Traditional | Quantase , Ltd. | 02/16/1999SE |
| K982307 | Wallac Neonatal Leucine Test Kit Model NL-1000JNB · Traditional | Wallac, Inc. | 02/02/1999SE |
| K974047 | Accuwell Phenylalanine AssayJNB · Traditional | Neometrics, Inc. | 12/05/1997SE |
| K963040 | Manual Phenylalanine TestJNB · Traditional | Bio-Rad | 10/01/1996SE |
| K960437 | Radias Phenylalanine TestJNB · Traditional | Bio-Rad | 08/16/1996SE |
| K961515 | Quantase Phenylalanine AssayJNB · Traditional | Shield Diagnostics, Ltd. | 06/12/1996SE |
| K926106 | Immuchem Phe-Mw EaJNB · Traditional | Icn Biomedicals, Inc. | 02/08/1995SE |
More from Icn Biomedicals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | 05/11/1993SE |
Questions and answers
When was Phenylalanine Test Kit cleared by the FDA?
Phenylalanine Test Kit (K943547) received a 510(k) decision of Substantially Equivalent on January 26, 1996, 554 days after the submission was received.
What is the product code of K943547?
The FDA product code is JNB – Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, a Class II (moderate risk) device regulated under 21 CFR 862.1555.