AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30
FDA 510(k) K001285 · Diagnostic Chemicals , Ltd.
510(k) numberK001285
Submission
- Device name
- AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- April 21, 2000
- Decision date
- June 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIF – Enzymatic Method, Ammonia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1065
- Specialty
- Clinical Chemistry
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| K051114 | Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional | Sentinel Ch. Srl | 11/25/2005SE |
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| K030873 | Randox AmmoniaJIF · Traditional | Randox Laboratories, Ltd. | 05/12/2003SE |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | Bayer Diagnostics Corp. | 12/24/2002SE |
| K021151 | Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional | Bayer Diagnostics Corp. | 07/13/2002SE |
| K003196 | Synchron Systems Ammonia ReagentJIF · Traditional | Beckman Coulter, Inc. | 12/22/2000SE |
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Questions and answers
When was AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30 cleared by the FDA?
AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30 (K001285) received a 510(k) decision of Substantially Equivalent on June 2, 2000, 42 days after the submission was received.
What is the product code of K001285?
The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.