The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Sickle Cell Reagent Set.
Device ID | K860420 |
510k Number | K860420 |
Device Name: | SICKLE CELL REAGENT SET |
Classification | Test, Sickle Cell |
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 | GHM |
CFR Regulation Number | 864.7825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-04 |
Decision Date | 1986-02-24 |