The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Chek-stix Control Strips For Urinalysis.
| Device ID | K931467 |
| 510k Number | K931467 |
| Device Name: | CHEK-STIX CONTROL STRIPS FOR URINALYSIS |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Contact | Rosanne Savol |
| Correspondent | Rosanne Savol HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1993-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414532844 | K931467 | 000 |
| 00630414532837 | K931467 | 000 |