The following data is part of a premarket notification filed by Medical Specialties Intl., Inc. with the FDA for Hema-trol Q-check.
| Device ID | K952385 |
| 510k Number | K952385 |
| Device Name: | HEMA-TROL Q-CHECK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL SPECIALTIES INTL., INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | W. Kevin Liddle |
| Correspondent | W. Kevin Liddle MEDICAL SPECIALTIES INTL., INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-09-25 |