Panels › Clinical Chemistry › Product code JIL · Class 2
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation 862.1340
0510(k)s in 12 months (81 all time)
1recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in JIL
| Company | 510(k)s | Recalls |
|---|---|---|
| Syn-Kit, Inc. | 11 | 0 |
| Tanabe U.S.A., Inc. | 8 | 0 |
| Teco Diagnostics | 8 | 0 |
| Kyoto Diagnostics, Inc. | 4 | 0 |
| Siemens Healthcare Diagnostics | 1 | 3 |
| Analyticon Biotechnologies AG | 3 | 0 |
| Arkray, Inc. | 3 | 0 |
| DFI Co., Ltd. | 3 | 0 |
| Macherey-Nagel GmbH & Co. KG | 2 | 1 |
| Miles Laboratories, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 1993 | K931897 | UROPAPER Tanabe U.S.A., Inc. | JIL |
| Jan 11, 1990 | K896454 | CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS Boehringer Mannheim Corp. | JIL |
| Jan 10, 1990 | K895282 | CHARISE CHARLES REAGENT STRIPS Lee Import Domestic Consulting | JIL |
| Jul 27, 1987 | K864544 | DIABETES RISK DETECTOR Pearce Clinical Laboratories, Inc. | JIL |
| Mar 6, 1987 | K870500 | MAJOR QUALITY GLUCOSE AND KETONES URINE TEST American Diagnostic Corp. | JIL |
| Oct 3, 1986 | K861255 | BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS Behring Diagnostics, Inc. | JIL |
| Jul 25, 1986 | K861733 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS Kyoto Diagnostics, Inc. | JIL |
| Jun 13, 1986 | K855239 | BIOTEL (TM)/ DIABETES American Diagnostic Corp. | JIL |
| Dec 18, 1984 | K843760 | UROPAPER EIKEN G Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843759 | UROPAPER EIKEN HAG Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843758 | UROPAPER EIKEN GK Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843757 | UROPAPER EIKEN AG Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843756 | UROPAPER EIKEN 5 Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843755 | UROPAPER EIKEN 6B Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843754 | UROPAPER EIKEN 7 Syn-Kit, Inc. | JIL |
| Dec 18, 1984 | K843753 | UROPAPER EIKEN GP Syn-Kit, Inc. | JIL |
| May 31, 1984 | K841714 | KYOTEST 2V, URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIL |
| May 31, 1984 | K841713 | KYOTEST UG URINE TEST REAGENT STRIP Kyoto Diagnostics, Inc. | JIL |
| May 14, 1984 | K834387 | YD STRIP GPH U21 Yd Pharmaceutical Corp. | JIL |
| May 14, 1984 | K834386 | YD STRIP GP U20 Yd Pharmaceutical Corp. | JIL |
| May 11, 1984 | K834385 | YD STRIP GLUCOSE U19 Yd Pharmaceutical Corp. | JIL |
| Apr 19, 1984 | K840829 | KYOTEST UGK Kyoto Diagnostics, Inc. | JIL |
| Sep 8, 1983 | K831600 | DIASTIX REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. | JIL |
| Jun 22, 1983 | K831498 | URI-TEST 3, INLAB REAGENT STRIPS-URINAL Laprol Scientific, Inc. | JIL |
| May 5, 1982 | K820594 | BIOSTRIP G Helena Laboratories | JIL |
| Dec 8, 1981 | K811816 | UROPAPER EIKEN UHAG Syn-Kit, Inc. | JIL |
| Jul 23, 1981 | K811818 | UROPAPER EIKEN UAG Syn-Kit, Inc. | JIL |
| Jul 15, 1981 | K811817 | UROPAPER EIKEN AG Syn-Kit, Inc. | JIL |
| Oct 25, 1977 | K771755 | 9-WAY URINE TEST WITH ASCORBIC Miles Laboratories, Inc. | JIL |
| Mar 21, 1977 | K761310 | MEGA-DIASTIX Miles Laboratories, Inc. | JIL |
| Mar 16, 1977 | K770271 | CHEMSTRIP G Boehringer Mannheim Corp. | JIL |
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