Double Antibody Albumin for Detect Microalbuminuri
FDA 510(k) K851338 · Diagnostic Products Corp.
510(k) numberK851338
Submission
- Device name
- Double Antibody Albumin for Detect Microalbuminuri
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- April 3, 1985
- Decision date
- April 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
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| 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 |
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Questions and answers
When was Double Antibody Albumin for Detect Microalbuminuri cleared by the FDA?
Double Antibody Albumin for Detect Microalbuminuri (K851338) received a 510(k) decision of Substantially Equivalent on April 7, 1986, 369 days after the submission was received.
What is the product code of K851338?
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.