The following data is part of a premarket notification filed by Icl Scientific with the FDA for Kova Trol I,ii, Iii Human Urine-dried.
| Device ID | K843565 |
| 510k Number | K843565 |
| Device Name: | KOVA TROL I,II, III HUMAN URINE-DRIED |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-10 |
| Decision Date | 1984-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855617006613 | K843565 | 000 |
| 00855617006330 | K843565 | 000 |
| 00855617006323 | K843565 | 000 |
| 00855617006309 | K843565 | 000 |
| 00855617006682 | K843565 | 000 |
| 00855617006675 | K843565 | 000 |
| 00855617006668 | K843565 | 000 |
| 00855617006651 | K843565 | 000 |
| 00855617006644 | K843565 | 000 |
| 00855617006637 | K843565 | 000 |
| 00855617006620 | K843565 | 000 |
| 00855617006316 | K843565 | 000 |
| 00855617006286 | K843565 | 000 |
| 00855617006262 | K843565 | 000 |
| 00850015517211 | K843565 | 000 |
| 00850015517204 | K843565 | 000 |
| 00855617006347 | K843565 | 000 |
| 00855617006354 | K843565 | 000 |
| 00855617006293 | K843565 | 000 |
| 00855617006255 | K843565 | 000 |
| 00855617006231 | K843565 | 000 |
| 00855617006217 | K843565 | 000 |
| 00855617006200 | K843565 | 000 |
| 00850015517150 | K843565 | 000 |
| 00850015517143 | K843565 | 000 |
| 00850015517136 | K843565 | 000 |
| 00855617006422 | K843565 | 000 |
| 00855617006415 | K843565 | 000 |
| 00855617006408 | K843565 | 000 |
| 00855617006392 | K843565 | 000 |
| 00855617006385 | K843565 | 000 |
| 00855617006378 | K843565 | 000 |
| 00855617006361 | K843565 | 000 |
| 00850015517198 | K843565 | 000 |