The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Speciality Urine 1,2.
| Device ID | K971405 |
| 510k Number | K971405 |
| Device Name: | SPECIALITY URINE 1,2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92614 |
| Contact | Ronald D Schaefer |
| Correspondent | Ronald D Schaefer CHIRON DIAGNOSTICS CORP. 17392 DAIMLER ST. Irvine, CA 92614 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-16 |
| Decision Date | 1997-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002024 | K971405 | 000 |
| 00847661001607 | K971405 | 000 |