Flow Pac Total Iron REAGENTS:2183,2349,2312,014339
FDA 510(k) K871284 · American Research Products Co.
510(k) numberK871284
Submission
- Device name
- Flow Pac Total Iron REAGENTS:2183,2349,2312,014339
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- March 31, 1987
- Decision date
- April 8, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
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| K051115 | Sentinel Iron LiquidJIY · Traditional | Sentinel Ch. Srl | 08/25/2005SE |
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| K020816 | Iron-Pc-Sl Assay Model # 151-10, 151-26JIY · Traditional | Diagnostic Chemicals , Ltd. | 05/14/2002SE |
| K013097 | Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003JIY · Traditional | Wiener Laboratories Saic | 11/13/2001SE |
| K981241 | IronJIY · Traditional | Abbott Laboratories | 05/01/1998SE |
| K973933 | Serum Iron-Sl Assay, Catalogue Numbers 157-10, 157-30JIY · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K972363 | Il Test IronJIY · Traditional | Instrumentation Laboratory CO | 08/15/1997SE |
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| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
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Questions and answers
When was Flow Pac Total Iron REAGENTS:2183,2349,2312,014339 cleared by the FDA?
Flow Pac Total Iron REAGENTS:2183,2349,2312,014339 (K871284) received a 510(k) decision of Substantially Equivalent on April 8, 1987, 8 days after the submission was received.
What is the product code of K871284?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.