Orgentec Micro-Albumin Pin Eia Assay
FDA 510(k) K960274 · Orgentec
510(k) numberK960274
Submission
- Device name
- Orgentec Micro-Albumin Pin Eia Assay
- Applicant
- Orgentec
Windham, NH, US - Received
- January 19, 1996
- Decision date
- March 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K222921 | Minuteful-kidney testJIR · Traditional | Healthy.Io, Ltd. | 09/08/2023SE |
| K210069 | Minuteful - kidney testJIR · Traditional | Healthy.Io, Ltd. | 07/06/2022SE |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional | ACON Laboratories, Inc. | 04/30/2015SE |
| K061419 | Teco Microalbumin 2-1 Combo StripsJIR · Traditional | Teco Diagnostics | 01/26/2007SE |
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | Diagnostic Chemicals, Ltd. (Usa) | 08/23/2002SE |
| K001810 | Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional | Flexsite Diagnostics, Inc. | 08/14/2000SE |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional | Diagnostic Chemicals , Ltd. | 02/01/2000SE |
| K992257 | New Multiples Reagent StripsJIR · Traditional | Bayer Corp. | 11/24/1999SE |
| K991315 | Microalbustix Reagent Strips (OTC)JIR · Traditional | Bayer Corp. | 11/12/1999SE |
| K983774 | UalbJIR · Traditional | Abbott Laboratories | 01/28/1999SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K954831 | Orgentec Anti-Rnp/Sm Pin Immuno AssayLKO · Traditional | 05/08/1996SE |
| K954830 | Orgentec Anti-Sm(Smith) Pin Immuno AssayLKP · Traditional | 05/08/1996SE |
| K954832 | Orgentec Anti-Ss-B(La) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954829 | Orgentec ANTI-JO-1 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954815 | Orgentec Anti-Ss-A(Ro) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954814 | Orgentec Anti-Scl 70 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K955134 | Orgentec Enascreen Elisa AssayLLL · Traditional | 03/20/1996SE |
| K955133 | Orgentec Enascreen Pin Immuno AssayLLL · Traditional | 03/20/1996SE |
| K953671 | Orgen Tec Anti-Dsdna Elisa AssayLRM · Traditional | 11/09/1995SE |
Questions and answers
When was Orgentec Micro-Albumin Pin Eia Assay cleared by the FDA?
Orgentec Micro-Albumin Pin Eia Assay (K960274) received a 510(k) decision of Substantially Equivalent on March 29, 1996, 70 days after the submission was received.
What is the product code of K960274?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.