The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Negative Control Strips For Urinalysis (chex-stix, Clinitek Auto 2000, Clinitex Atlas).
| Device ID | K943780 |
| 510k Number | K943780 |
| Device Name: | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | HERAEUS KULZER, INC. 1127 MYRTLE ST. Elkhart, IN 46514 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. 1127 MYRTLE ST. Elkhart, IN 46514 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-03 |
| Decision Date | 1994-10-31 |