The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Inorganic Phosphorus Reagent Set.
| Device ID | K860628 |
| 510k Number | K860628 |
| Device Name: | INORGANIC PHOSPHORUS REAGENT SET |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David Callender |
| Correspondent | David Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-03-14 |