9-WAY Urine Test with Ascorbic
FDA 510(k) K771755 · Miles Laboratories, Inc.
510(k) numberK771755
Submission
- Device name
- 9-WAY Urine Test with Ascorbic
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- September 16, 1977
- Decision date
- October 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1340
- Specialty
- Clinical Chemistry
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| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | DFI Co., Ltd. | 02/16/2018SE |
| K171083 | iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional | Iris Diagnostics, A Division of Iris… | 05/12/2017SE |
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| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | Teco Diagnostics, Inc. | 07/22/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | Teco Diagnostics | 07/24/2015SE |
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Questions and answers
When was 9-WAY Urine Test with Ascorbic cleared by the FDA?
9-WAY Urine Test with Ascorbic (K771755) received a 510(k) decision of Substantially Equivalent on October 25, 1977, 39 days after the submission was received.
What is the product code of K771755?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.