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 |