The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Hemastix Reagent Strips.
| Device ID | K905396 |
| 510k Number | K905396 |
| Device Name: | HEMASTIX REAGENT STRIPS |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Product Code | JIO |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1991-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414550596 | K905396 | 000 |
| 00630414549101 | K905396 | 000 |