The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Flame Photometer Standard.
| Device ID | K860501 |
| 510k Number | K860501 |
| Device Name: | FLAME PHOTOMETER STANDARD |
| Classification | Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate |
| Applicant | MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Contact | Ronald Devita |
| Correspondent | Ronald Devita MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield, NJ 07080 |
| Product Code | JLJ |
| CFR Regulation Number | 862.1315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-04-07 |