The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Lactate Dehydrogenase (ldh) Reagent Set.
| Device ID | K860349 |
| 510k Number | K860349 |
| Device Name: | LACTATE DEHYDROGENASE (LDH) REAGENT SET |
| Classification | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David L Callender |
| Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | CFH |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-02-28 |