Reagent Strips for Urinalysis
FDA 510(k) K811342 · Miles Laboratories, Inc.
510(k) numberK811342
Submission
- Device name
- Reagent Strips for Urinalysis
- Applicant
- Miles Laboratories, Inc.
Elkhart, IN, US - Received
- May 12, 1981
- Decision date
- September 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRE – Refractometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2800
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954977 | Urine Reagents STRIPS-8 Parameters (Modification)JRE · Traditional | Teco Diagnostics | 03/11/1996SE |
| K941906 | Model 2730 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941903 | Model 2740 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941901 | Model 2721 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941905 | Model 3461 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941904 | Model A300CL Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941902 | Model 3471 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K891681 | Dilectron Urinary Conductivity ProbeJRE · Traditional | Gyrus Medical , Ltd. | 05/01/1990SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | Kyoto Diagnostics, Inc. | 07/16/1984SE |
| K831213 | Specific Gravity InstrumentJRE · Traditional | Iris | 06/30/1983SE |
More from Iris
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Reagent Strips for Urinalysis cleared by the FDA?
Reagent Strips for Urinalysis (K811342) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 112 days after the submission was received.
What is the product code of K811342?
The FDA product code is JRE – Refractometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2800.