Quantase Phenylalanine Assay
FDA 510(k) K961515 · Shield Diagnostics, Ltd.
510(k) numberK961515
Submission
- Device name
- Quantase Phenylalanine Assay
- Applicant
- Shield Diagnostics, Ltd.
Dundee, GB - Received
- April 10, 1996
- Decision date
- June 12, 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
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|---|---|---|---|
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| 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 |
| K943547 | Phenylalanine Test KitJNB · Traditional | Isolab, Inc. | 01/26/1996SE |
| K926106 | Immuchem Phe-Mw EaJNB · Traditional | Icn Biomedicals, Inc. | 02/08/1995SE |
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| K963525 | Diastat Anti-Glomerular Basement Membrane KitDBL · Traditional | 11/07/1996SE |
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Questions and answers
When was Quantase Phenylalanine Assay cleared by the FDA?
Quantase Phenylalanine Assay (K961515) received a 510(k) decision of Substantially Equivalent on June 12, 1996, 63 days after the submission was received.
What is the product code of K961515?
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.