The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Liquid Urine Control.
| Device ID | K890577 |
| 510k Number | K890577 |
| Device Name: | KENLOR LIQUID URINE CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
| Contact | Som, Ph.d. |
| Correspondent | Som, Ph.d. KENLOR INDUSTRIES, INC. 8130 MCFADDEN AVE., SUITE 105 Westminster, CA 92683 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040004104 | K890577 | 000 |
| 30858512007014 | K890577 | 000 |
| 10858512007034 | K890577 | 000 |
| 30858512007045 | K890577 | 000 |
| 10858512007065 | K890577 | 000 |
| 10858512007072 | K890577 | 000 |
| 30858512007083 | K890577 | 000 |
| 30858512007090 | K890577 | 000 |
| 30858512007113 | K890577 | 000 |
| 30858512007120 | K890577 | 000 |
| 30858512007021 | K890577 | 000 |
| 30858512007052 | K890577 | 000 |
| 30858512007106 | K890577 | 000 |
| 30858512007137 | K890577 | 000 |
| 00304040004098 | K890577 | 000 |
| 30858512007007 | K890577 | 000 |