Panels › Clinical Chemistry › Product code JJB · Class 1
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Regulation 862.1115
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Amatech International, Inc. | 1 | 0 |
| Genesis Labs, Inc. | 1 | 0 |
| Syn-Kit, Inc. | 1 | 0 |
| Teco Diagnostics | 1 | 0 |
| Wako Chemicals USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 1995 | K943436 | URINE REAGENT STRIPS-8 PARAMETERS Teco Diagnostics | JJB |
| Aug 8, 1994 | K943008 | BIOSCAN REAGENT STRIPS Genesis Labs, Inc. | JJB |
| Sep 22, 1987 | K873553 | WAKO(TM) PRETEST 8A Wako Chemicals USA, Inc. | JJB |
| Dec 4, 1986 | K862806 | URINE DIAGNOSTIC REAGENT STRIPS Amatech International, Inc. | JJB |
| Jan 11, 1984 | K833521 | REAGENT TESTS STRIP COMBINATIONS Syn-Kit, Inc. | JJB |
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