The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Quantify(901).
| Device ID | K972710 |
| 510k Number | K972710 |
| Device Name: | QUANTIFY(901) |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia, CA 94510 |
| Contact | James D Lapicola |
| Correspondent | James D Lapicola HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia, CA 94510 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-08-15 |
| Summary: | summary |