Phosphorus Test (Phos) Item Number 65416
FDA 510(k) K945322 · Emd Chemicals, Inc.
510(k) numberK945322
Submission
- Device name
- Phosphorus Test (Phos) Item Number 65416
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- November 1, 1994
- Decision date
- December 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1580
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional | Seppim S.A.S. | 05/06/2011SE |
| K072141 | S40 Clinical Analyzer, S Test Ip, S Test UaCEO · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K041643 | Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional | Beckman Coulter, Inc. | 08/18/2004SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | Elan Diagnostics | 03/07/2003SE |
| K022312 | Piccolo Phosphorus Test SystemCEO · Traditional | Abaxis, Inc. | 09/05/2002SE |
| K013095 | Wiener Lab.Fosfatemia UV, Models 1X100 ML Cat.N 1382321, 4X20 ML Cat.N 1009311CEO · Traditional | Wiener Laboratories Saic | 11/16/2001SE |
| K003912 | Phosphorus ReagentCEO · Traditional | Jas Diagnostics, Inc. | 02/21/2001SE |
| K003012 | Raichem Phosporus ReagentCEO · Special | Hemagen Diagnostics, Inc. | 10/25/2000SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | A.P. Total Care, Inc. | 08/02/1999SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | Boehringer Mannheim Corp. | 12/01/1998SE |
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| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
| K840883 | Unipak 100 Analyzer, 65156 & ChemistrJJE · Traditional | 05/16/1984SE |
Questions and answers
When was Phosphorus Test (Phos) Item Number 65416 cleared by the FDA?
Phosphorus Test (Phos) Item Number 65416 (K945322) received a 510(k) decision of Substantially Equivalent on December 7, 1994, 36 days after the submission was received.
What is the product code of K945322?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.