JJB · Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1115 · Class 1
Overview
| Product Code | JJB |
|---|---|
| Device Name | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| Regulation | 21 CFR 862.1115 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | Teco Diagnostics | Apr 24, 1995 | SESE |
| K943008 | BIOSCAN REAGENT STRIPS | Genesis Labs, Inc. | Aug 8, 1994 | SESE |
| K873553 | WAKO(TM) PRETEST 8A | Wako Chemicals USA, Inc. | Sep 22, 1987 | SESE |
| K862806 | URINE DIAGNOSTIC REAGENT STRIPS | Amatech International, Inc. | Dec 4, 1986 | SESE |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | Syn-Kit, Inc. | Jan 11, 1984 | SESE |
Top Applicants
- Amatech International, Inc. — 1 clearance
- Genesis Labs, Inc. — 1 clearance
- Syn-Kit, Inc. — 1 clearance
- Teco Diagnostics — 1 clearance
- Wako Chemicals USA, Inc. — 1 clearance
